2,717 Pharmaceutical Services jobs in the United States
Clinical Pharmacist, Pharmaceutical Services Consultant

Posted 27 days ago
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Job Description
The **Clinical Pharmacist, Pharmaceutical Services Consultant,** will analyze new-to-market medications and propose use criteria to MOHealthNet for utilization by Missouri Medicaid participants.
**Responsibilities**
+ Providing ad-hoc query results to the client, MOHealthNet, to support clinical program recommendations.
+ Proactively bringing new drug criteria and analyses to the department with recommendations on coverage, clinical criteria, Pharmacoeconomics, and pharmacy practice guidelines.
+ Providing ad-hoc query results to the client to support clinical program recommendations.
+ Leading weekly and quarterly scheduled client clinical meetings. Being available during business hours to respond to client requests and questions.
+ Authoring medication reviews for use by MOHealthNet and the Missouri Rare Disease Advisory Committee.
+ Researching to implement new interventions, creating ad hoc reports, and answering client, provider, and staff inquiries.
+ Working with the account team to maintain current interventions based on updates to clinical guidelines and treatment recommendations.
**Requirements**
+ Have a PharmD degree.
+ Possess a current Missouri Pharmacist license in good standing or be able to obtain a Missouri Pharmacist license within 6 months of hire.
+ Demonstrate experience with Pharmacy Benefit Management, Prior Authorization, and knowledge of pharmacy point-of-sale and adjudication rules.
**Preferred**
+ Display understanding of Prior Authorization applications, Pro DUR, and Retro DUR.
+ Medicaid experience.
**Flexible Working**
At Conduent, we want you to be yourself. We recognize that everyone is different and that how people want to work and deliver at their best is different for everyone too.
In this role, you can expect the following working conditions:
+ **Remote work** : Enjoy the convenience of working from home and maximize your time by unplugging at the end of your workday.
**Working For You**
Perks and rewards designed for you:
+ Health and Welfare Benefits: Our health and welfare benefits can be tailored to fit you and your family's needs and start on the first day of employment.
+ Retirement Savings: We will support you as you save for your future.
+ Employee Discounts: We offer you access to a vast selection of global, national, and local discounts on merchandise, services, travel, and more.
+ Career Growth Opportunities: We help you thrive, so together, we can grow. We provide opportunities to advance your career with a vast portfolio of businesses and a global footprint.
+ Paid Training: Earn while you learn and continue to grow with access to award-winning learning platforms throughout your Conduent career.
+ Paid time off: We provide attractive paid time off packages designed for you to enjoy your life away from work.
+ Great Work Environment: We are proud of our award-winning culture and the recognition we've received for our diversity efforts.
**Join Us**
At Conduent, we are one team, one mission. We understand that our success is directly related to the success of our associates. We strive to create a culture where you can:
Bring your authentic self to work.
Grow and thrive, both personally and professionally.
Make a difference with our clients, in our communities, and with the millions of people we support.
When you join Conduent, you are engaged in creating the future - both our company's and your own. With more than 60,000 associates across 24 countries, we will provide you the opportunity to grow with a team of people who will challenge and inspire you to be the best!
Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated salary range for this role is $95,000-$123,500.
Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law.
For US applicants: People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded: click here to access or download the form ( . Complete the form and then email it as an attachment to . You may also click here to access Conduent's ADAAA Accommodation Policy ( .
Business Development Pharmaceutical Sales, Services Manager

Posted 18 days ago
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Job Description
The ZebraSci Business Development Services Manager, reporting to the Director of Combination Products and Technical Services, will work with pharmaceutical and biotechnology companies to accelerate their combination product development programs with the help of ZebraSci services.
**Job Description**
We are **the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a **maker of possible** with us.
**About the role:**
The Business Development Services Manager will oversee existing accounts and develop business with new emerging accounts within the parenteral drug delivery space. The role will work closely with the pharmaceutical and biotechnology clients to define combination product development requirements and translate those into service opportunities, maintain business relationships, manage existing business, oversee sales and delivery of services.
**Key responsibilities will include:**
+ Achieve or exceed the sales goals as established in the annual or multi-annual plan for the territory, based on growth rate consistent with the average of the reference markets
+ Prepare and submit an Annual Plan for assigned accounts including unit sales forecast and written comments on either opportunities or threats.
+ Prepare customer proposals and statements of work with company technical experts to support customer combination product development requirements
+ Collaborate and work directly with BD commercial and technical resources as required to support customer activities
+ Establish detailed working relationships with all customer contacts - provide best in class service level to the customer
+ Approach opportunities with customers with a problem-solving mentality and develop effective solutions with ZebraSci team in line with ZebraSci technical capabilities
+ Manage proposal response process, including detailed RFP requirements, proposal development, and inputs from various sources
+ Generate new leads, identify and contact decision-makers, screen/qualify potential business opportunities, select the deals in line with strategies, and lead and facilitate sales logistics (i.e. internal/external customer visit preparation)
+ Support deal structure and pricing with business/market-based value analysis; negotiate prices for proactive bids and proposals
**Education and experience required:**
+ 5+ years in technical business to business selling to pharmaceutical companies or related experience.
+ Experience in pharmaceutical, combination product or pharmaceutical industry preferred
+ BS/BA preferably in a science or engineering discipline; alternatively in Business Management with relevant medical device/pharmaceutical industry working experience
+ Excellent interpersonal skills, solid organization/prioritization skills and passion for customer centricity
+ Ability to multitask and be adaptable to a fast pace and dynamic business environment
+ Ability to travel ~25%
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**Why Join Us?**
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
**Primary Work Location**
USA NJ - Franklin Lakes
**Additional Locations**
USA NJ Branchburg
**Work Shift**
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Filling Technician (Pharmaceutical Industry)
Posted 3 days ago
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Job Description
**Salary/Pay Rate/Compensation:**
$24 on days, $27 on nights
Contract to Hire positions thru Kelly Services
works hours Days 6am-6:30pm on a 2-2-3 schedule
Nights: 6pm-6:30am on a 2-2-3 schedule
**Why you should apply to be a Filling Technician (Pharmaceutical):**
- Join a cutting-edge pharmaceutical company dedicated to innovation and quality.
- Work in a safe and compliant environment that prioritizes cGMP standards.
- Be part of a collaborative team focused on continuous improvement and process optimization.
- Opportunities for professional development and skill enhancement in a dynamic industry.
**What's a typical day as a Filling Technician ? You'll be:**
- Operating and maintaining filling machinery, ensuring the smooth flow of product and performing line clearances.
- Conducting in-process monitoring, including visual and physical checks of materials and executing filter integrity testing as needed.
- Completing batch record entries and maintaining accurate documentation in compliance with cGMPs and SOPs.
**This job might be an outstanding fit if you:**
- Have a high school diploma or equivalent; experience in a manufacturing or pharmaceutical environment is preferred.
- Possess knowledge of cGMP practices and safety procedures, including familiarity with Material Safety Data Sheets.
- Are capable of working in a fast-paced, team-oriented environment and are flexible to adapt to changing demands.
**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 all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about, so let's get to work. Apply to be a Filling Technician today!
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.
Get a complete career fit with Kelly ® .
You're looking to keep your career moving onward and upward, and we're here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.
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.
Clinical Research Regulatory Affairs Specialist

Posted 27 days ago
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Job Description
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Regulatory Affairs Specialist
Job Profile Title
Clinical Research Regulatory Specialist B
Job Description Summary
Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn),regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.
Job Description
Job Responsibilities
+ Participate in the coordination of unit/division clinical research, including but not limited to Phase I-IV clinical trials.
+ Prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees.
+ Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required.
+ Resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
+ Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
+ Facilitate the development unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, as well as, to provide direct regulatory/compliance guidance.
+ Perform additional regulatory duties as assigned.
Qualifications
+ Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required . At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$62,000.00 - $63,600.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .
Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
+ Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
+ Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
+ Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
+ Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
+ Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
+ Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
+ Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
+ University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
+ Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
+ Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
+ Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
+ Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: University of Pennsylvania's special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University's commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.
Regulatory Affairs Director
Posted today
Job Viewed
Job Description
The Center for Elders’ Independence is a PACE (Program of All-Inclusive Care for the elderly) organization (PO) that uses an interdisciplinary team approach for care planning and implementing purposeful high quality, affordable, and integrated health care services to the elderly. Our elderly meet PACE requirements as prescribed by CMS and are referred to as participants. Our PO includes Adult Day Health Centers and primary care clinics, promoting participant autonomy, quality of life and the ability for individuals to live in their communities
THE POS I TION : The Director of Regulatory Affairs will develop and execute healthcare policy analysis and s trategic oversight of CEI’s regulatory strategy to ensure compliance with federal and California PACE requirements ( Centers for Medicare & Medicaid Services (CMS) and California Department of Health Care Services (DHCS) ). This D irector provides strategic guidance, supports compliance program management, and serves as the primary liaison with government agencies, particularly CMS and DHCS . This leader will manage regulatory submissions, guide cross ‑ functional teams through complex healthcare policy and regulatory matters, and support audits, inspections, and ongoing regulatory reporting. The role requires deep experience with healthcare policy , PACE federal and state regulatory frameworks, strong project and stakeholder management skills, and proven leadership in healthcare regulatory/compliance environments .
DUTIES AND RESPONSIBILITIES:
- Regulatory Affairs : Develop and implement regulatory strategies that support CEI’s PACE program growth and ongoing compliance with CMS and DHCS requirements. Act as the primary point of contact for CMS and state agencies , which involves managing relationships, responding to inquiries, and representing the PACE organization during audits or investigations . Lead preparation, submission, tracking, and maintenance of PACE applications, amendments, notices, and other regulatory filings to CMS and DHCS. Partner with legal counsel, external compliance consultants, and the Compliance Officer to coordinate filings, audits, and regulatory responses.
- Policy I nterpretation and S trategy: Monitor, interpret and communicate new federal and state regulations, policy changes, and guidance documents to determine their impact on PACE operations. Assess operational impact and develop and communicate a regulatory strategy to senior leadership to implement required changes.
- Compliance P rogram M anagement : Implement and m onitor effective compliance program elements . C reat e policies and procedures, ensur e annual risk assessments are performed, and manag e an annual auditing plan s .
- Risk A ssessment and M itigation: Identify and assess potential compliance risks and develop strategies to mitigate them. This includes resolving any instances of non-compliance and implementing corrective action plans. Conduct regulatory risk assessments; identify, escalate, and mitigate regulatory risks in collaboration with the General Counsel, Compliance Officer, and operational leaders. Review marketing and promotional materials for regulatory compliance. Oversee annual compliance reviews, audits, testing, and monitoring of internal controls related to PACE operations and regulatory filings.
- Process Improvement: Design, enhance, and maintain compliance workflows, systems, and internal controls to support efficient regulatory operations . Represent CEI on multidisciplinary continuous improvement projects and ensure regulatory perspectives are integrated into organizational strategy
- Training and E ducation: Draft, update, and maintain policies, procedures, and guidance documents; provide regulatory education across departments. Create and deliver training programs to ensure all staff and contractors understand and comply with regulatory requirements. This fosters a culture of compliance throughout the organization.
QUALIFICATIONS : Deep, working knowledge of healthcare policy, PACE federal and state regulatory frameworks, including CMS and DHCS requirements.
- 15+ years of progressive experience in healthcare policy analysis, regulatory affairs, compliance, and PACE operations — including direct experience working with or responding to CMS and/or DHCS.
- Master’s degree in Healthcare Administration, Regulatory Affairs, Public Health, Juris Doctorate, or a related field (or equivalent experience).
- Proven ability to lead cross-functional teams and manage enterprise-level regulatory programs.
- Training leader, facilitator and mentor on Kaizen, A3 and data collection processes.
- Strong written and verbal
The above job description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. CEI reserves the right to change job descriptions, site assignments, and or work hours as required by the needs of the program. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Center for Elders’ Independence is a PACE (Program of All- Inclusive Care for the Elderly) organization that uses an interdisciplinary team approach to care planning and care implementation for the purpose of providing high quality, affordable, integrated health care services to the elderly, including an Adult Day Health Center, and promoting autonomy, quality of life and the ability of individuals to live in their communities. Unlike other healthcare plans, CEI is not a "fee-for-service" plan. It is a “capitation” healthcare plan. CEI is paid a set amount for each person enrolled in our program, whether or not that individual seeks care. We are a growing company that offers stability and continues to thrive.
Director, Regulatory Affairs

Posted today
Job Viewed
Job Description
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
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.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Director, Regulatory Affairs

Posted today
Job Viewed
Job Description
This leader is required to be based in **Tempe, AZ** with a hybrid work schedule of three days per week in office. Relocation support can be provided.
**Key Areas of Responsibility:**
+ Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence
+ Recognized as thought leader in advocacy activities
+ Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes
+ Accesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategy
+ Integrates regulatory considerations into the organization's global product entry and exit strategy
+ Identifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical products
+ Manages negotiations with regulatory authorities on complex issues throughout the product lifecycle
+ Influences changing regulations and guidance
+ Interfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distribution
+ Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs
+ Leads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycle
+ Leads the development and execution of good regulatory practices and policy
+ Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products
+ Leads the regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during preapproval/clinical phases
+ Participates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessment
+ Approves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changes
+ Reviews and approves publicly disseminated information on product submission approval status
+ Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets
+ Implement regulatory system changes to support evolving regulations and international standards
+ Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities
+ Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission
+ Establish standard process to ensure appropriate resolution and management of the responsible task owner
+ Chair meetings required to drive closure of regulatory issues
+ Manage and provide updates for regulatory metrics. Implement appropriate enhancements
+ Represent regulatory processes during internal and external audits
+ Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
+ Recruit, select, and on-board top talent
+ Develop talent within team to increase performance. Actively address performance issues on team
+ Maintain a high level of team engagement
+ Participate in advocacy activities of a more advanced strategic nature
**Education / Work Experience:**
+ BS in Engineering or other relevant field of study
+ Minimum of 10 years' experience
+ Master's Degree or equivalent preferred
+ RAC desired
**Knowledge / Competencies:**
+ Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
+ Demonstrated expertise in regulatory systems in a regulated environment
+ Demonstrated project management skills
+ Demonstrated verbal, written, and interpersonal communication skills
+ Demonstrated ability to work in a team environment, interact effectively with management from other functions
+ Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets
+ Demonstrated ability to initiate work
+ Demonstrated analytical ability
+ Demonstrated ability to make effective decisions
+ Experience with recruiting, people development
+ Influence across the organization
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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Director, Regulatory Affairs

Posted 1 day ago
Job Viewed
Job Description
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
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.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Director, Regulatory Affairs

Posted today
Job Viewed
Job Description
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
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.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_