9 Environmental Protection Agency jobs in Federal
Regulatory Affairs Senior Advisor
Posted today
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Become a Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and build a better tomorrow. In this job, you'll be part of the State Regulatory Operations team at Southern California Edison, primarily responsible for leading portions of its General Rate Case (GRC) and other cost forecast recovery proceedings at the California Public Utilities Commission (CPUC). This position will develop and implement regulatory strategies for Transmission & Distribution/Strategic Planning and Engineering's critical and complex projects, programs, and issues. This position will also support these efforts by understanding the strategic and tactical impacts of regulatory decisions and effectively advocating SCE's positions to various audiences both internally and externally. Partner swith stakeholders such as Law and Finance and effectively communicate/collaborate with OU subject matter experts, witnesses, executive steering teams, and external parties. This includes advising leadership on financial, business, and operational on regulatory risks and considerations, as well as collaborating closely with these organizations to ensure financial data with SCE's GRC is accurate, timely, and consistent between GRCs and other regulatory filings through application, discovery, rebuttal, and hearing phases. This includes influencing and leading cross-functional teams, collaborating with employees at all levels and areas within the company, and engaging with some of SCE's key external stakeholders. This is a highly collaborative and challenging role where you will be exposed to critical elements of the GRC and other company issues. As a Regulatory Affairs Senior Advisor, your work will help power our planet, reduce carbon emissions and create cleaner air for everyone. Are you ready to take on the challenge to help us build the future?
**Responsibilities**
+ Develops business requirements, performs gap analysis, and identifies strategies for controls and risk mitigation
+ Facilitates training and ensuring the effective remediation of potential non-compliant situations
+ Supports legislative strategy and legislative language development to advance or defend company positions
+ Conducts audit reviews to ensure that the company stays compliant with the policies and standards enforced by relevant agencies
+ Identifies significant regulatory challenges and commercial opportunities, for the current and future regulatory environments
+ Advises and counsels on new consumer products and product structures and compliance with changing regulatory rules and varying political environment
+ Oversees and implements the organization's compliance reporting activities
+ Leads regulatory report submission for the company
+ Provides guidance to cross-functional organizations on considering preventative measures on corrective action responses
+ A material job duty of all positions within the Company is ensuring the protection of all its physical, financial and cybersecurity assets, and properly accessing and managing private customer data, proprietary information, confidential medical records, and other types of highly sensitive information and data with the highest standards of conduct and integrity.
**Minimum Qualifications**
+ Ten or more years of experience with regulatory filings/proceedings and compliance standards.
Preferred Qualifications
+ Bachelor's or Graduate degree in Science, Engineering, Economics, Law, Finance, Communications, Public Policy, or related field
+ Experience supporting testimony development for the general rate case (GRC)
+ Experience leading and managing cross-functional teams in the development of risk-informed planning, operational analysis, or financial analysis
+ Experience creating and delivering presentations covering financial impacts and regulatory strategies to senior leaders or stakeholders
+ Experience reviewing historical, pending, and new business processes to identify potential impacts on company operations, including recommendations to address the operational impacts.
+ Experience working in a utility company
+ Experience identifying, managing, leading, and supporting ad-hoc short-term projects as requested by management.
+ Ability to follow Edison safety protocols and safe work practices.
+ Proficiency with the following software tools: Microsoft Word, Excel, Power Point and Project.
Additional Information
+ This position's work mode is hybrid. The employee will report to an SCE facility for a set number of days with the option to work remotely on the remaining days. Unless otherwise noted, employees are required to work and reside in the state of California. Further details of this work mode will be discussed at the interview stage. The work mode can be changed based on business needs.
+ Visit our Candidate Resource ( page to get meaningful information related to benefits, perks, resources, testing information, hiring process, and more!
+ Position will require up to 10% traveling and being out in the field throughout the SCE service territory.
+ Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
+ Relocation does not apply to this position.
About Southern California Edison
The people at SCE don't just keep the lights on. Our mission is so much bigger. We're fueling the kind of innovation that's changing an entire industry, and quite possibly the planet. Join us and create a future with cleaner energy, while providing our customers with the safety and reliability they demand. At SCE, you'll have a chance to grow personally and professionally, making a real impact in Southern California and around the world.
Southern California Edison is a proud Equal Opportunity Employer, including disability and protected veteran status.
We are committed to ensuring that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations at .
Regulatory Affairs Specialist (Global)
Posted today
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Regulatory Affairs
Los Angeles County, CA, US
Pay Rate Low: 65 | Pay Rate High: 80
+ Added - 15/10/2024
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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.
Senior Principal Regulatory Affairs Specialist
Posted today
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Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
**Responsibilities:**
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains.
+ Provide technical expertise and regulatory direction to project teams throughout the product lifecycle.
+ Proactively communicate strategy, risks, and critical issues to stakeholders and senior leadership.
+ Influence internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives.
+ Serve as primary regulatory point of contact with Health Authorities and manage ongoing relationships.
+ Participate in assigned due diligence activities for business development and acquisitions.
+ Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDAs and amendments/supplements.
+ Serve as RA representative on facility/site Local Change Management Boards.
+ Ensure operational excellence, compliance, and timely execution of deliverables.
+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements.
+ Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways.
+ Support interactions with Health Authorities for development programs.
+ Ensure high-quality submissions by proofreading and checking documents for accuracy and consistency.
+ Contribute to continuous learning, process improvement, and knowledge-sharing initiatives.
+ Mentor and coach team members in regulatory strategy and submission excellence.
+ Monitor and report on performance metrics to drive operational effectiveness.
+ Participate in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.
**Qualifications:**
+ Bachelor degree or equivalent, Master degree preferred
+ Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work with key national opinion leaders, and advisory boards
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 to $180,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Senior Principal Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics).
**Responsibilities:**
+ Interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Provide technical expertise internally and/or externally as subject matter expert
+ Participate in external industry forums (such as trade associations, committees and regulatory boards) as required and influence externally
+ Represent BNL in external committees and boards as required
+ Coach and mentor individuals on subject matter expertise
+ Provide guidance and direction regarding regulatory strategy to project teams
+ Participate in assigned due diligence activities for business development and acquisitions
+ Utilize multiple regulatory databases to ensure the stringent accuracy of information for creation of cosmetics, OTC Drug Facts and nutritional/natural health products in the US and/or Canada
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains
+ Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDA amendments/supplements
+ Review raw materials and formulations, provide advice to product development teams and give guidance on potential regulatory compliance issues
+ Point of contact with Health Authorities and ability to manage the relationship with Health Authorities
**Qualifications:**
+ Bachelor's degree or equivalent; Master's degree preferred
+ Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional, and/or Cosmetics) regulated environment
+ Thorough understanding of regulatory processes and information systems.
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ Ability to influence internal and external key stakeholders and KOL's
+ Ability to handle multiple tasks and meet deadlines
+ Strong capability to contribute in a team environment
+ Ability to support internal/external business stakeholders
+ Excellent organizational and communication skills; both oral and written
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to author pre-market and post market registration documents
+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
+ Focused ability to influence operational excellence and performance metrics
+ Risk adverse where needed with the ability to identify potential solutions to complex problems
+ Capability to effectively work independently
+ Experience in practical understanding, interpretation, and application of US regulatory requirements for cosmetic products (MoCRA), including state-specific requirements and CPSC requirements preferred
+ Experiencewith innovative approaches and general regulatory requirements for Rx to OTC switch preferred
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval.
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment.
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work effectively with key national opinion leaders, and advisory boards
+ Working knowledge of FDA regulations / Code of Federal Regulations (CFR)
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s):((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 and $180,000 per year. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 10 days ago
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Job Description
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; Advanced degree preferred.
- 8+ years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements for drug development and marketing authorization.
- Proven experience in preparing and submitting various regulatory dossiers (e.g., INDs, NDAs, MAAs).
- Familiarity with ICH guidelines and regional regulatory specifics.
- Excellent analytical, problem-solving, and organizational skills.
- Strong written and verbal communication skills.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Experience working with regulatory agencies.
- Detail-oriented with a commitment to quality and compliance.
Associate Director, Advertising and Promotion Regulatory Affairs
Posted today
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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. **This position will be based in Santa Monica, CA or Remote, depending on the identified candidate.**
+ 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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
**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.
Sr Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote)
Posted today
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At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.
Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.
**Position Summary:**
Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, Promotion, and Labeling Lead will be responsible for managing regulatory strategy and material approvals within their areas of responsibility, ensuring alignment with the overall company strategy.
In collaboration with Global Regulatory Affairs leads and cross functional teams, this individual will develop and implement regulatory strategies for labeling, advertising, and promotion. They will ensure regulatory compliance, provide strategic regulatory guidance, and support product launches and commercialization throughout the product lifecycle in assigned territories.
A key aspect of this role is fostering strong coordination and collaboration across internal departments and stakeholders, including Marketing, Technical Operations, Legal, Clinical, Commercial, Medical Affairs, Pharmacovigilance, and Compliance teams.
**Key Responsibilities:**
- Guide, direct and coordinate the strategic labeling/advertising/promotion and planning for company products from a regulatory perspective for pre and post launch campaigns including strategic label development from target product profile (TPP), company core data sheet (CCDS) end to end development and maintenance
- Maintain oversight and efficiency of Veeva promotional, label systems for managing review and approval of labeling and advertising/promotional materials.
- Lead and manage periodic meetings, metrics for labelling charter. Provide input into or develop required processes, including transitioning of acquired products into company systems and associated standard operating procedures to ensure consistency of approach and regulatory compliance for areas of responsibility.
- This position has responsibility for overseeing staff, coordinating with cross functional teams in assembling regulatory documents such as pre-IND, IND and efficacy supplements by clearly articulating key regulatory considerations for review and submission to Competent Health Authorities and other regulatory agencies (as requested).
- Organize cross functional team meetings on management of change controls, labeling supplements and implementation of new/changes to approved product labels, prescribing information, medication guides, patient information leaflets and carton/container artworks
- Direct point of contact and signatory for FDA APLB (Advertising Promotion Labeling Branch) submissions and advisory comments for all BLAs (Biological License Applications) and commercial products
**Experience and Education Requirements:**
- Bachelor's degree in science with 10+ years of broad professional experience gained from previous Regulatory Affairs roles. Regulatory affairs certified (RAC) preferred
- Demonstrated, hands-on experience leading, managing, and preparing regulatory submissions and knowledge in the preparation of electronic submission
- Experience in reviewing and approving change controls, advertising and promotion as well as non-promotional materials within a complex specialty/branded commercial pharmaceutical organization. Preferred candidates will have experience in critically reviewing and implementing collaborative solutions to diverse promotional and MRL scenarios.
- Good interpersonal skills as well as a sound strategic business perspective with appropriate consideration to risk is required to ensure that effective regulatory and compliance practices are fully integrated into all associated development and post-marketing activities
- Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America. In-depth understanding of the product commercialization and labeling development process is desired. #LI-SF1
The approximate pay range for this position is $160,000.00 to $200,000.00. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location.
Nestlé offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. Incentives and/or benefit packages may vary depending on the position. Learn more at About Us | Nestlé Careers (nestlejobs.com) ( .
It is our business imperative to remain a very inclusive workplace.
To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestlé home.
The Nestlé Companies are equal employment opportunity employers. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at or please dial 711 and provide this number to the operator: .
This position is not eligible for Visa Sponsorship.
Review our applicant privacy notice before applying at Requisition:
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Senior Environmental Compliance Manager - (On-call position)
Posted today
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**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**AECOM** is seeking a **Senior-level Environmental Compliance Manager** to support a large southern California gas utility company projects throughout the Los Angeles, San Bernardino, and Ventura regions in California. This position can be report to any of AECOM's southern California offices including San Diego, Los Angeles, Orange, or San Luis Obispo.
**_*This is a remote, on-call (as needed position). *_**
**The responsibilities of this position include, but are not limited to:**
+ Act as an Environmental Compliance Manager on multiple projects; including review and interpretation of project plans and permits; staffing surveyors, monitors, and technical experts; and compliance coordination with clients, contractors, and resource agencies.
+ Work closely with clients, contractors, and internal staff on complex projects involving biological, cultural, and paleontological resource protection; species surveys; environmental permitting; mitigation, noise abatement, hazardous materials, and implementation of Stormwater Pollution Prevention Plans.
+ Prepare and provide senior review of technical memorandums, environmental permitting documents, and other technical reports.
**About AECOM's Environment Business Line**
Join AECOM to be part of an expert global team who is connected through a well-developed, worldwide, internal technical practice network through which you can learn from and brainstorm with the best in the world. AECOM is an industry-leading, world class environmental firm, and we want you to succeed within it. We respect and encourage your own pathway to excellence via our Freedom to Grow initiative.
AECOM is known for our award-winning technical excellence, leading-edge science and innovative project delivery. We provide sustainable solutions for some of the world's most challenging issues. Our global clients and their projects span a variety of market sectors and geographies and require innovative technical solutions to solve wide-ranging environmental problems.
**Qualifications**
**Minimum Qualifications:**
+ Bachelor's degree in biology, environmental science, environmental engineering, land use planning, or a related field.
+ 6 years of relevant experience or demonstrated equivalency of experience and/or education as an Environmental Compliance Manager on utility projects involving regulatory compliance, preconstruction surveys, and construction monitoring for a variety of environmental resources.
+ Valid U.S. Driver's license is required.
+ Due to the nature of the work, US Citizenship is required.
**Preferred Skills/Experience:**
+ 8+ years of relevant experience in environmental compliance.
+ Prior experience with gas utility company construction projects as a field monitor or coordinator is highly desired.
+ Familiarity with permit application requirements, and the typical challenges and strategies related to environmental permitting.
+ Knowledge of and experience with the California Environmental Quality Act and National Environmental Policy Act (NEPA).
+ Experience preparing preconstruction and post construction reports and deliverables.
+ Experience as a task lead or Project Manager with managing staffing and budgets.
+ Experience in a client-facing role.
+ Familiar with the agencies having jurisdiction over special-status species and hydrologic resources.
+ Excellent oral and written communication skills with both clients and internal staff.
+ Experience as a lead reviewer of technical reports.
+ Experienced in developing project scopes and estimating project costs.
+ Positive attitude and adaptability to changing priorities in a fast-paced work environment.
+ Good organizational skills and a strong detail-oriented work style.
+ Prior environmental consulting experience is highly desired.
**Additional Information**
+ Sponsorship is not offered for this position now or in the future
Offered rate of compensation will be based on individual education, qualifications, experience, and work location. The range for this position is $50 to $0.
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of 16.1 billion in fiscal year 2024. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community-where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.
**ReqID:** J
**Business Line:** Environment
**Business Group:** DCS
**Strategic Business Unit:** West
**Career Area:** Science
**Work Location Model:** Remote
**Compensation:** USD 50 - USD 70 - hourly
Manager of Environmental, Health, and Safety Field Compliance
Posted today
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Job Description
In this role, you will provide support, leadership, and direction in the implementation and monitoring of safety and health programs in the Company's retail store operations. This role provides hands-on oversight and interaction with the Company's retail store operations, to include safety and health and sanitation requirements. This role will be responsible for overseeing retail store operations in specified geographic areas of the country.
***This is a field position based in North Central-West to West Coast regions of the U.S, preferably near a major airport.***
**Principal Duties & Responsibilities:**
+ In a field support role, engage in on-site training; auditing; site assessments; store support of safety and health initiatives.
+ Evaluate store environments against OSHA and industry-specific health and safety requirements and guidelines.
+ Work to improve Associate health and safety processes in retail store environments.
+ Enforce compliance with OSHA and Company standards.
+ Partner with retail store operations in conducting training and auditing programs concerning environmental, health and safety.
+ Provide leadership to store operations field leaders on regulatory processes and procedures for assigned areas.
+ Seek and analyze situations or conditions with potential regulatory implications.
+ Document EH&S issues and follow prescribed processes and protocol to identify solutions in retail store operations.
+ Demonstrate depth and breadth of knowledge in hazard recognition, evaluation, and control, and serve as safety subject matter expert to field leadership.
+ Provide support on store requests for safety and health assistance and responses to regulatory visits or internal audit findings.
+ Represent the Company by interfacing with government regulatory agencies and working to resolve regulatory issues and risk mitigation of future issues.
+ Ensure stores follow-up on environmental, health and safety compliance opportunities.
+ Serve as contact for government and outside entities such as OSHA and the Food and Drug Administration.
+ Report to Director, Environmental, Health and Safety Field Compliance on field compliance with Company safety and health policies, deploying training and resources as needed.
**Minimum Requirements / Qualifications:**
+ Bachelor's degree or equivalent in Safety, Law, Human Resources, or Environmental.
+ 5 years' experience in Safety, Human Resources, Asset Protection, or Environmental.
+ Knowledge of OSHA standards, guidelines; and EH&S processes; regulatory inspection processes.
+ Excellent people skills: the ability to quickly develop relationships and communicate with multiple internal and external business partners.
+ Strong training and auditing background.
+ Analytical thinking and problem solving; able to creatively solve problems, innovative approaches where required with ability to prioritize work and meet deadlines.
+ Knowledge of regulatory standards and industry best practices related to health and safety compliance.
+ Detail-oriented and coordination of multiple priorities in a fast-paced dynamic environment.
+ Ability to work flexible schedule.
+ Travel approximately 80%.
**Desired Qualifications:**
+ OSHA 30 Certification.
+ Professional certifications, such as GSP, ASP, CSP and/or ARM preferred.
**Start Rate = $100,000 -$120,000 based on experience (plus 20% Bonus and Equity)**
**The company offers Health, Dental, & Vision, a flexible spending account, life and disability insurance benefits, a 401k plan, PTO, paid holidays annually, and an employee stock purchase plan.**
Full time
19337 Victory Blvd,Reseda,California
Environmental Health & Safety
Dollar Tree