16 Environmental Protection Agency jobs in Federal
Regulatory Affairs Project Manager
90504 Torrance, California
Kelly Science, Engineering, Technology & Telecom
Posted 7 days ago
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Job Description
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Regulatory Affairs Project Manager (Cosmetics & OTC Drug Industry)
Kelly Science & Clinical s seeking a Regulatory Affairs Project Manager for a project-based position with the potential to transition into a full-time role. If you have a passion for ensuring compliance and expertise in the cosmetics and OTC drug industry, now is your chance to make an impact with a leading manufacturer. Take the next step in your regulatory career with PMLwhere expertise meets opportunity!
Location: Torrance, CA
Position Type: Contract (potential for extension or hire)
Shift: M-F 8a-5p
Pay Range: 80-100K
About The Role
We are seeking a highly skilled Regulatory Affairs Project Manager with specialized experience in the cosmetics and OTC drug industry. This opportunity is initially project-based, with the possibility of transitioning into a full-time Regulatory Manager role upon successful performance and cultural fit.
Key Responsibilities
- Analyze the current list of open regulatory requests, ensuring all are addressed and up to date.
- Classify requests by required resources, complexity, and estimated completion time.
- Identify and define standard regulatory documents and processes that PML must maintain as a manufacturer to ensure ongoing compliance.
- Recommend effective approaches for non-standard, complex, or resource-intensive requests, which may include:
- Advising clients to seek external regulatory consultants.
- Identifying and recommending software systems for regulatory automation.
- Proposing additional internal hires or outsourced support, as needed.
- Minimum 5 years in regulatory affairs within the cosmetics and OTC drug sector; contract manufacturing background is highly desirable.
- In-depth understanding of FDA regulations, OTC drug monograph compliance, cosmetic labeling, product claims, and related documentation.
- Demonstrated experience managing complex regulatory workflows, documentation, and cross-functional coordination.
- Strong skills in analyzing regulatory requests, resource planning, and process optimization.
- Excellent written and verbal communication skills, with proven ability to work collaboratively with internal teams and external stakeholders.
- Familiarity with regulatory software systems and automation tools.
- Experience advising on external regulatory consultant engagements.
- Ability to train and onboard new internal or outsourced compliance staff.
- Exceptional organizational skills and attention to detail.
Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, were obsessed with where it can take you. To us, its about more than simply accepting your next job opportunity. Its the fuel that powers every next step of your life. Its the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifejust ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Seniority level
- Seniority level Associate
- Employment type Full-time
- Job function Science
- Industries Staffing and Recruiting
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0
Regulatory Affairs Project Manager
90509 Torrance, California
Kelly Services
Posted 5 days ago
Job Viewed
Job Description
**Regulatory Affairs Project Manager (Cosmetics & OTC Drug Industry)**
Kelly® Science & Clinical s seeking a **Regulatory Affairs Project Manager** for a project-based position with the potential to transition into a full-time role. If you have a passion for ensuring compliance and expertise in the cosmetics and OTC drug industry, now is your chance to make an impact with a leading manufacturer. Take the next step in your regulatory career with PML-where expertise meets opportunity!
**Location:** Torrance, CA
**Position Type:** Contract to hire (3-6 month conversion)
**Shift:** M-F 8a-5p
**Pay Range:** 80-100K
**About the Role**
We are seeking a highly skilled Regulatory Affairs Project Manager with specialized experience in the cosmetics and OTC drug industry. This opportunity is initially project-based, with the possibility of transitioning into a full-time Regulatory Manager role upon successful performance and cultural fit.
**Key Responsibilities**
+ Analyze the current list of open regulatory requests, ensuring all are addressed and up to date.
+ Classify requests by required resources, complexity, and estimated completion time.
+ Identify and define standard regulatory documents and processes that PML must maintain as a manufacturer to ensure ongoing compliance.
+ Recommend effective approaches for non-standard, complex, or resource-intensive requests, which may include:
+ Advising clients to seek external regulatory consultants.
+ Identifying and recommending software systems for regulatory automation.
+ Proposing additional internal hires or outsourced support, as needed.
**Qualifications**
+ Minimum 5 years in regulatory affairs within the cosmetics and OTC drug sector; contract manufacturing background is highly desirable.
+ In-depth understanding of FDA regulations, OTC drug monograph compliance, cosmetic labeling, product claims, and related documentation.
+ Demonstrated experience managing complex regulatory workflows, documentation, and cross-functional coordination.
+ Strong skills in analyzing regulatory requests, resource planning, and process optimization.
+ Excellent written and verbal communication skills, with proven ability to work collaboratively with internal teams and external stakeholders.
**Preferred Skills**
+ Familiarity with regulatory software systems and automation tools.
+ Experience advising on external regulatory consultant engagements.
+ Ability to train and onboard new internal or outsourced compliance staff.
+ Exceptional organizational skills and attention to detail.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Kelly® Science & Clinical s seeking a **Regulatory Affairs Project Manager** for a project-based position with the potential to transition into a full-time role. If you have a passion for ensuring compliance and expertise in the cosmetics and OTC drug industry, now is your chance to make an impact with a leading manufacturer. Take the next step in your regulatory career with PML-where expertise meets opportunity!
**Location:** Torrance, CA
**Position Type:** Contract to hire (3-6 month conversion)
**Shift:** M-F 8a-5p
**Pay Range:** 80-100K
**About the Role**
We are seeking a highly skilled Regulatory Affairs Project Manager with specialized experience in the cosmetics and OTC drug industry. This opportunity is initially project-based, with the possibility of transitioning into a full-time Regulatory Manager role upon successful performance and cultural fit.
**Key Responsibilities**
+ Analyze the current list of open regulatory requests, ensuring all are addressed and up to date.
+ Classify requests by required resources, complexity, and estimated completion time.
+ Identify and define standard regulatory documents and processes that PML must maintain as a manufacturer to ensure ongoing compliance.
+ Recommend effective approaches for non-standard, complex, or resource-intensive requests, which may include:
+ Advising clients to seek external regulatory consultants.
+ Identifying and recommending software systems for regulatory automation.
+ Proposing additional internal hires or outsourced support, as needed.
**Qualifications**
+ Minimum 5 years in regulatory affairs within the cosmetics and OTC drug sector; contract manufacturing background is highly desirable.
+ In-depth understanding of FDA regulations, OTC drug monograph compliance, cosmetic labeling, product claims, and related documentation.
+ Demonstrated experience managing complex regulatory workflows, documentation, and cross-functional coordination.
+ Strong skills in analyzing regulatory requests, resource planning, and process optimization.
+ Excellent written and verbal communication skills, with proven ability to work collaboratively with internal teams and external stakeholders.
**Preferred Skills**
+ Familiarity with regulatory software systems and automation tools.
+ Experience advising on external regulatory consultant engagements.
+ Ability to train and onboard new internal or outsourced compliance staff.
+ Exceptional organizational skills and attention to detail.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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1
Regulatory Affairs Specialist (Global)
90006 Los Angeles, California
Astrix Technology
Posted 5 days ago
Job Viewed
Job Description
**Regulatory Affairs Specialist (Global)**
Regulatory Affairs
Los Angeles County, CA, US
Pay Rate Low: 65 | Pay Rate High: 80
+ Added - 15/10/2024
Apply for Job
One of our innovative clients who specializes in the Nutraceutical space is seeking a Sr. Regulatory Affairs Specialist (Global) to help expand portfolio. This is a great opportunity for individuals who are looking for a new challenge with full autonomy & ability to build out their own team.
Direct Hire Position (Salary range: $100-150K+ DOE)
Relocation assistance may be provided.
Equity included in compensation package.
**Responsibilities:**
+ Prepare & maintain necessary documentation for regulatory submissions, inspections and import activities.
+ Ensure compliance with licensing regulations in all applicable jurisdictions.
+ Responsible for maintaining relationships and working with suppliers.
+ Manage regulatory assessment and guidance on product compliance topics including change controls, deviations and GMP investigations.
+ Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.
+ Assist in determining regulatory requirements for registration, approval, and maintenance of existing drugs and potential new drug products in global markets.
+ Establish clear priorities and bring key projects to completion on time, within budget and of significant impact to the growth of the business.
+ Provide technical support and expertise on API related, IND/NDA, and 503A/503B.
+ Effectively communicate project needs and deliverables to upper management as needed.
**Requirements:**
+ PharmD Degree and active pharmacy license.
+ Strong proven hands-on regulatory affairs experience with APIs.
+ Strong knowledge of 503A & 503B regulations.
+ Effective planning, organizational and task management skill
+ Detail-oriented and goal-driven individual
+ Excellent facilitation and creative problem-solving skills
+ Excellent communication skills while simultaneously being able to work independently
+ Demonstrated ability to prepare complex documents/submissions and presentations
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Regulatory Affairs
Los Angeles County, CA, US
Pay Rate Low: 65 | Pay Rate High: 80
+ Added - 15/10/2024
Apply for Job
One of our innovative clients who specializes in the Nutraceutical space is seeking a Sr. Regulatory Affairs Specialist (Global) to help expand portfolio. This is a great opportunity for individuals who are looking for a new challenge with full autonomy & ability to build out their own team.
Direct Hire Position (Salary range: $100-150K+ DOE)
Relocation assistance may be provided.
Equity included in compensation package.
**Responsibilities:**
+ Prepare & maintain necessary documentation for regulatory submissions, inspections and import activities.
+ Ensure compliance with licensing regulations in all applicable jurisdictions.
+ Responsible for maintaining relationships and working with suppliers.
+ Manage regulatory assessment and guidance on product compliance topics including change controls, deviations and GMP investigations.
+ Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.
+ Assist in determining regulatory requirements for registration, approval, and maintenance of existing drugs and potential new drug products in global markets.
+ Establish clear priorities and bring key projects to completion on time, within budget and of significant impact to the growth of the business.
+ Provide technical support and expertise on API related, IND/NDA, and 503A/503B.
+ Effectively communicate project needs and deliverables to upper management as needed.
**Requirements:**
+ PharmD Degree and active pharmacy license.
+ Strong proven hands-on regulatory affairs experience with APIs.
+ Strong knowledge of 503A & 503B regulations.
+ Effective planning, organizational and task management skill
+ Detail-oriented and goal-driven individual
+ Excellent facilitation and creative problem-solving skills
+ Excellent communication skills while simultaneously being able to work independently
+ Demonstrated ability to prepare complex documents/submissions and presentations
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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2
Vice President of Regulatory Affairs
90079 Los Angeles, California
Confidential
Posted today
Job Viewed
Job Description
Vice President of Regulatory Affairs
About the Company
Prominent AI-powered clean tech company
Industry
Renewables & Environment
Type
Privately Held
About the Role
The Company is in search of a Director or VP of Regulatory Affairs to take on a pivotal role in driving regulatory strategy, influencing policy, and promoting the adoption of advanced grid and customer analytics across North America. The successful candidate will be responsible for leading regulatory engagement with state and regional bodies, advocating for the integration of smart meter analytics in rate cases and grid modernization plans, and supporting utilities in securing funding for innovative energy programs. This high-impact position requires a professional with a strategic mindset for policy, innovation, and market enablement, as well as strong communication and stakeholder engagement skills.
Applicants for this role at the company should have a background in regulatory affairs, particularly within the context of a leading energy software company in the US. Deep experience with utility regulation, including PUCs, GRCs, IRPs, and TEPs, is essential. The role also demands a candidate who can provide thought leadership through various channels, such as conferences, public comments, and industry engagement. The ideal candidate will be a proactive advocate for the company's mission, with a focus on accelerating the adoption of advanced technologies in the energy sector.
Travel Percent
Less than 10%
Functions
- Business Development
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3
Vice President, Global Regulatory Affairs
90079 Los Angeles, California
Confidential
Posted today
Job Viewed
Job Description
Vice President, Global Regulatory Affairs
About the Company
Forward-thinking biotech company
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Vice President, Head of Global Regulatory Affairs to join their team. The successful candidate will be responsible for providing strategic and operational leadership in all regulatory functions, ensuring compliance with global health authority regulations, and driving the company's business objectives. This role involves leading the planning and execution of critical regulatory milestones, including the preparation, review, and submission of various key filings. The ideal candidate will be a forward-thinking regulatory leader with a deep understanding of the evolving regulatory landscape, particularly in the context of innovative therapies. They will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.
Key responsibilities for the Vice President, Head of Global Regulatory Affairs include creating and executing global regulatory strategies, maintaining regulatory knowledge of US, EU, and global regulations, and managing all activities related to interactions with health authorities. The role requires a candidate with a strong background in regulatory affairs, including hands-on experience in leading clinical trials and a proven track record of successful interactions with global regulatory agencies. Experience in oncology and/or hematology is preferred, as is a background in bio-pharmaceuticals. The candidate should possess excellent communication skills, strong leadership abilities, and the capacity to work in an agile, small company environment. A degree in MD, Ph.D., or Pharm D. is preferred, along with at least 15 years of experience in the field.
Travel Percent
Less than 10%
Functions
- General Management
- Operations
- Strategy
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4
Director of Regulatory Affairs ( {{city}})
92808 Anaheim, California
Kelly Science, Engineering, Technology & Telecom
Posted 5 days ago
Job Viewed
Job Description
Director of Quality and Regulatory Affairs
Kelly Science & Clinical is seeking a Director of Quality and Regulatory Affairs for a direct-hire position at a cutting-edge client in Anaheim, CA. If youre passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary: $140,000-160,000
Schedule: Day Shift. Onsite
Overview
The Client is an industry-leading company thats driving innovation in the nutraceutical sector. In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing leadership and development to assigned teams and staff.
Responsibilities:
- Establish, implement, and manage the overall regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all Client products.
- Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local and federal regulatory requirements.
- Continuously identify opportunities to improve the Quality System, product quality, simplify processes, and reduce the costs of quality.
- Manage quality and regulatory staff and departmental resource needs.
- Create and lead a high-performing, innovative management team that attracts, recruits, develops, and retains exceptional staff.
Qualifications:
- Bachelors degree in life sciences or related field required, advanced degree or certification in Quality or Regulatory preferred.
- 10+ years of experience in the nutraceutical industry, including management experience.
- Extensive experience in quality, regulatory, and dietary supplement industry, with strategic knowledge of USA and global regulations.
- Proven experience interfacing with regulatory bodies such as FDA, Notified Bodies, and Competent Authorities.
- Excellent knowledge of Quality Systems Regulations, cGMP, and 21 CFR Part 11, 111, and 117.
- Strong statistical knowledge, teamwork orientation, workplace safety, and complaint handling systems.
- Outstanding verbal and written communication skills, critical thinking, and organizational abilities.
- Demonstrated success in building and leading high-performing, complex tea
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5
GRC Regulatory Affairs and Governance Manager
90209 Beverly Hills, California
City National Bank
Posted today
Job Viewed
Job Description
*TRANSFORMATION MGR-SR PROGRAM MGR*
WHAT IS THE OPPORTUNITY?
Position leads the strategic programs across the Consumer, Commercial and Private Banking segments by driving strategy execution and organizational change management (OCM) programs. Transformation initiatives may be related to revenue growth, cost or process efficiencies, customer experience, technical implementations and/or risk reduction. Initiatives require proficiency in business case analysis, process and operating model redesign, organizational change management, and structured project management.
WHAT WILL YOU DO?
* Develops, manages and leads execution of three year strategic transformation program roadmap.
* Manages a portfolio of strategic initiatives and supporting program managers.
* Organizes, leads, and facilitates cross-LOB process design, measurement and re-engineering initiatives that will encompass an end to end analysis and future state design that requires specialized knowledge or skills critical to the redesign effort in a matrix leadership environment
* Develops improvement approaches within businesses and across lines of businesses that are holistic, customer focused to understanding business processes and workflow through CNB and identify and help prioritize new initiatives to drive business strategy, mitigate potential risks and control gaps, financial return, and/or positive customer impact
* Develops root cause analysis and business case for proposed strategy, technology, staff and structure changes, including cost estimates
* Provides advanced statistical analysis for business leaders, project teams, and managers as required. In addition, provide basic and advanced measurement approaches and mechanisms to ensure we are managing the process and producing the designed results
* Manages implementation of major technology programs including design, build, test, deployment and control phases in an agile methodology
* May include the direct management of process analysts and consultants
* The sharing of lessons learned and best practices with others throughout the organization when appropriate
WHAT DO YOU NEED TO SUCCEED?
*Required Qualifications**
* Bachelor's Degree or equivalent
* Minimum 10 years of experience leading consumer and commercial banking strategic transformation programs for customer-facing or operations functions (e.g., account opening, client servicing, customer experience, compliance and risk management, etc.) - with deep subject matter expertise in consumer / commercial banking, wealth management and treasury management processes
* Minimum 7 years of experience with banking-related process and operating model redesign, major reorganizations, governance design, data analytics, and/or innovative change adoption programs)
* Minimum 7 years of prior consulting expertise, either at a major consulting firm (Deloitte, PwC, strategy houses, etc.) or as an internal consultant supporting EVP/SVP level executives
*Additional Qualifications*
* Experience in deploying digital platforms, integrated to CRM, document management and servicing platforms. Salesforce CRM and FIS / Bottomline servicing experience very strong positive.
* Extensive experience in consumer / commercial operating model evaluation and design
* Experience leading multiple transformations at regional or national banks
* Experience leading large multi-platform technology deployments, including full life-cycle management from concept through deployment - particular emphasis on structured delivery, complex integration and testing, agile development
* Technology strategy, core banking platform experience a strong +
* Proven experience at sourcing staff and building high performance teams
* Excellent executive communication skills, presentation development and delivery
*WHAT'S IN IT FOR YOU?*
*Compensation*Starting base salary: $141,830 - $263,408 per year. Exact compensation may vary based on skills, experience, and location. This job is eligible for bonus and/or commissions.
*Benefits and Perks*
At City National, we strive to be the best at whatever we do, including the benefits and perks we offer our colleagues including:
* Comprehensive healthcare coverage, including Medical, Dental and Vision plans, available the first of the month following start date
* Generous 401(k) company matching contribution
* Career Development through Tuition Reimbursement and other internal upskilling and training resources
* Valued Time Away benefits including vacation, sick and volunteer time
* Specialized health and family planning benefits including fertility benefits, and cancer, diabetes and musculoskeletal support programs
* Career Mobility support from a dedicated recruitment team
* Colleague Resource Groups to support networking and community engagement
Get a more detailed look at our US
Since day one we've always gone further than the competition to help our clients, colleagues and communities flourish. City National Bank was founded in 1954 by entrepreneurs for entrepreneurs and that legacy of integrity, community and unparalleled client relationships continues today. City National is a subsidiary of Royal Bank of Canada, one of North America's leading diversified financial services companies. To learn more about City National and our dynamic company culture, visit us at AND EQUAL OPPORTUNITY EMPLOYMENT*
City National Bank fosters an inclusive environment where all forms of diversity are valued and leveraged to make us a better company and employer. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, veteran status or other basis protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
*Represents basic qualifications for the position. To be considered for this position, you must at least meet the required qualifications. careers.cnb.com accepts applications on an ongoing basis, until filled.
#LI-JR1
#CR-JR
WHAT IS THE OPPORTUNITY?
Position leads the strategic programs across the Consumer, Commercial and Private Banking segments by driving strategy execution and organizational change management (OCM) programs. Transformation initiatives may be related to revenue growth, cost or process efficiencies, customer experience, technical implementations and/or risk reduction. Initiatives require proficiency in business case analysis, process and operating model redesign, organizational change management, and structured project management.
WHAT WILL YOU DO?
* Develops, manages and leads execution of three year strategic transformation program roadmap.
* Manages a portfolio of strategic initiatives and supporting program managers.
* Organizes, leads, and facilitates cross-LOB process design, measurement and re-engineering initiatives that will encompass an end to end analysis and future state design that requires specialized knowledge or skills critical to the redesign effort in a matrix leadership environment
* Develops improvement approaches within businesses and across lines of businesses that are holistic, customer focused to understanding business processes and workflow through CNB and identify and help prioritize new initiatives to drive business strategy, mitigate potential risks and control gaps, financial return, and/or positive customer impact
* Develops root cause analysis and business case for proposed strategy, technology, staff and structure changes, including cost estimates
* Provides advanced statistical analysis for business leaders, project teams, and managers as required. In addition, provide basic and advanced measurement approaches and mechanisms to ensure we are managing the process and producing the designed results
* Manages implementation of major technology programs including design, build, test, deployment and control phases in an agile methodology
* May include the direct management of process analysts and consultants
* The sharing of lessons learned and best practices with others throughout the organization when appropriate
WHAT DO YOU NEED TO SUCCEED?
*Required Qualifications**
* Bachelor's Degree or equivalent
* Minimum 10 years of experience leading consumer and commercial banking strategic transformation programs for customer-facing or operations functions (e.g., account opening, client servicing, customer experience, compliance and risk management, etc.) - with deep subject matter expertise in consumer / commercial banking, wealth management and treasury management processes
* Minimum 7 years of experience with banking-related process and operating model redesign, major reorganizations, governance design, data analytics, and/or innovative change adoption programs)
* Minimum 7 years of prior consulting expertise, either at a major consulting firm (Deloitte, PwC, strategy houses, etc.) or as an internal consultant supporting EVP/SVP level executives
*Additional Qualifications*
* Experience in deploying digital platforms, integrated to CRM, document management and servicing platforms. Salesforce CRM and FIS / Bottomline servicing experience very strong positive.
* Extensive experience in consumer / commercial operating model evaluation and design
* Experience leading multiple transformations at regional or national banks
* Experience leading large multi-platform technology deployments, including full life-cycle management from concept through deployment - particular emphasis on structured delivery, complex integration and testing, agile development
* Technology strategy, core banking platform experience a strong +
* Proven experience at sourcing staff and building high performance teams
* Excellent executive communication skills, presentation development and delivery
*WHAT'S IN IT FOR YOU?*
*Compensation*Starting base salary: $141,830 - $263,408 per year. Exact compensation may vary based on skills, experience, and location. This job is eligible for bonus and/or commissions.
*Benefits and Perks*
At City National, we strive to be the best at whatever we do, including the benefits and perks we offer our colleagues including:
* Comprehensive healthcare coverage, including Medical, Dental and Vision plans, available the first of the month following start date
* Generous 401(k) company matching contribution
* Career Development through Tuition Reimbursement and other internal upskilling and training resources
* Valued Time Away benefits including vacation, sick and volunteer time
* Specialized health and family planning benefits including fertility benefits, and cancer, diabetes and musculoskeletal support programs
* Career Mobility support from a dedicated recruitment team
* Colleague Resource Groups to support networking and community engagement
Get a more detailed look at our US
Since day one we've always gone further than the competition to help our clients, colleagues and communities flourish. City National Bank was founded in 1954 by entrepreneurs for entrepreneurs and that legacy of integrity, community and unparalleled client relationships continues today. City National is a subsidiary of Royal Bank of Canada, one of North America's leading diversified financial services companies. To learn more about City National and our dynamic company culture, visit us at AND EQUAL OPPORTUNITY EMPLOYMENT*
City National Bank fosters an inclusive environment where all forms of diversity are valued and leveraged to make us a better company and employer. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, veteran status or other basis protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
*Represents basic qualifications for the position. To be considered for this position, you must at least meet the required qualifications. careers.cnb.com accepts applications on an ongoing basis, until filled.
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6
Director of Quality and Regulatory Affairs
92805 Anaheim, California
Kelly Services
Posted 5 days ago
Job Viewed
Job Description
**Director of Quality and Regulatory Affairs**
Kelly® Science & Clinical is seeking a **Director of Quality and Regulatory Affairs** for a **direct-hire** position at a cutting-edge client in **Anaheim, CA.** If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
**Salary: $140,000-160,000**
**Schedule: Day Shift. Onsite**
**Overview**
The Client is an industry-leading company that's driving innovation in the nutraceutical sector. In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing leadership and development to assigned teams and staff.
**Responsibilities:**
+ Establish, implement, and manage the overall regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all Client products.
+ Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local and federal regulatory requirements.
+ Continuously identify opportunities to improve the Quality System, product quality, simplify processes, and reduce the costs of quality.
+ Manage quality and regulatory staff and departmental resource needs.
+ Create and lead a high-performing, innovative management team that attracts, recruits, develops, and retains exceptional staff.
**Qualifications:**
+ Bachelor's degree in life sciences or related field required, advanced degree or certification in Quality or Regulatory preferred.
+ 10+ years of experience in the nutraceutical industry, including management experience.
+ Extensive experience in quality, regulatory, and dietary supplement industry, with strategic knowledge of USA and global regulations.
+ Proven experience interfacing with regulatory bodies such as FDA, Notified Bodies, and Competent Authorities.
+ Excellent knowledge of Quality Systems Regulations, cGMP, and 21 CFR Part 11, 111, and 117.
+ Strong statistical knowledge, teamwork orientation, workplace safety, and complaint handling systems.
+ Outstanding verbal and written communication skills, critical thinking, and organizational abilities.
+ Demonstrated success in building and leading high-performing, complex teams.
**Competencies:**
+ People Manager competencies: Building talent, driving for results, Customer focus, Driving for innovation, Emotional intelligence.
+ Strategic thinking
+ Leadership, coaching, and mentoring
+ Financial management
+ Analysis and problem solving
**Work Environment:**
+ The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
+ Occasionally exposed to moving mechanical parts, fumes, airborne particles, and risk of electrical shock.
+ Noise level is usually moderate.
+ Required to use personal protective equipment while in the plant.
+ Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus.
**What happens next:**
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
p#1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Kelly® Science & Clinical is seeking a **Director of Quality and Regulatory Affairs** for a **direct-hire** position at a cutting-edge client in **Anaheim, CA.** If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
**Salary: $140,000-160,000**
**Schedule: Day Shift. Onsite**
**Overview**
The Client is an industry-leading company that's driving innovation in the nutraceutical sector. In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing leadership and development to assigned teams and staff.
**Responsibilities:**
+ Establish, implement, and manage the overall regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all Client products.
+ Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local and federal regulatory requirements.
+ Continuously identify opportunities to improve the Quality System, product quality, simplify processes, and reduce the costs of quality.
+ Manage quality and regulatory staff and departmental resource needs.
+ Create and lead a high-performing, innovative management team that attracts, recruits, develops, and retains exceptional staff.
**Qualifications:**
+ Bachelor's degree in life sciences or related field required, advanced degree or certification in Quality or Regulatory preferred.
+ 10+ years of experience in the nutraceutical industry, including management experience.
+ Extensive experience in quality, regulatory, and dietary supplement industry, with strategic knowledge of USA and global regulations.
+ Proven experience interfacing with regulatory bodies such as FDA, Notified Bodies, and Competent Authorities.
+ Excellent knowledge of Quality Systems Regulations, cGMP, and 21 CFR Part 11, 111, and 117.
+ Strong statistical knowledge, teamwork orientation, workplace safety, and complaint handling systems.
+ Outstanding verbal and written communication skills, critical thinking, and organizational abilities.
+ Demonstrated success in building and leading high-performing, complex teams.
**Competencies:**
+ People Manager competencies: Building talent, driving for results, Customer focus, Driving for innovation, Emotional intelligence.
+ Strategic thinking
+ Leadership, coaching, and mentoring
+ Financial management
+ Analysis and problem solving
**Work Environment:**
+ The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
+ Occasionally exposed to moving mechanical parts, fumes, airborne particles, and risk of electrical shock.
+ Noise level is usually moderate.
+ Required to use personal protective equipment while in the plant.
+ Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus.
**What happens next:**
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
p#1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
View Now
7
Associate Director, Advertising and Promotion Regulatory Affairs
90403 Santa Monica, California
Kite Pharma
Posted 7 days ago
Job Viewed
Job Description
Associate Director, Regulatory Affairs, Advertising And Promotion
At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the US business to meet its commercial needs in support of patients and in a compliant manner. Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion.
Responsibilities include:
- Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
- Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).
- Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.
- Serve as a liaison to the FDA's Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
- Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance.
- Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC.
- Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
Basic Qualifications:
- Doctorate and 2+ years of relevant industry experience OR
- Master's and 8+ years of relevant industry experience OR
- Bachelor's and 10+ years of relevant industry experience OR
- Associate and 12+ years of relevant industry experience OR
- High School Diploma/GED and 14+ years of relevant industry experience
Preferred Qualifications:
- Regulatory review of promotional materials for prescription drug and/or biologic products
- Oncology, immunology, and/or other relevant therapeutic area experience is desirable.
- An advanced degree is also desirable.
- Experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
- Excellent verbal and written communication skills and interpersonal skills are desired.
- Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
- Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
- The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate, and other non-promotional initiatives in other departments.
The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
View Now
8
Associate Director, Advertising and Promotion Regulatory Affairs
90407 Santa Monica, California
Gilead Sciences, Inc.
Posted 5 days ago
Job Viewed
Job Description
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
**Job Description**
At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the US business to meet its commercial needs in support of patients and in a compliant manner. Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion.
+ Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
+ Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).
+ Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.
+ Serve as a liaison to the FDA's Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
+ Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance.
+ Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC.
+ Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
Basic Qualifications:
+ Doctorate and 2+ years of relevant industry experience OR
+ Master's and 8+ years of relevant industry experience OR
+ Bachelor's and 10+ years of relevant industry experience OR
+ Associate and 12+ years of relevant industry experience OR
+ High School Diploma/GED and 14+ years of relevant industry experience
Preferred Qualifications:
+ Regulatory review of promotional materials for prescription drug and/or biologic products
+ Oncology, immunology, and/or other relevant therapeutic area experience is desirable.
+ An advanced degree is also desirable.
+ Experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
+ Excellent verbal and written communication skills and interpersonal skills are desired.
+ Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
+ Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
+ The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.
The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
**Job Description**
At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the US business to meet its commercial needs in support of patients and in a compliant manner. Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion.
+ Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
+ Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).
+ Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.
+ Serve as a liaison to the FDA's Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
+ Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance.
+ Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC.
+ Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
Basic Qualifications:
+ Doctorate and 2+ years of relevant industry experience OR
+ Master's and 8+ years of relevant industry experience OR
+ Bachelor's and 10+ years of relevant industry experience OR
+ Associate and 12+ years of relevant industry experience OR
+ High School Diploma/GED and 14+ years of relevant industry experience
Preferred Qualifications:
+ Regulatory review of promotional materials for prescription drug and/or biologic products
+ Oncology, immunology, and/or other relevant therapeutic area experience is desirable.
+ An advanced degree is also desirable.
+ Experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
+ Excellent verbal and written communication skills and interpersonal skills are desired.
+ Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
+ Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
+ The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.
The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
View Now
9