- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with global regulations and… more
- Bausch Health (Bridgewater, NJ)
- Director , Regulatory Affairs (Global Labeling) Job Location: Bridgeport, Connecticut, USA | Danbury, Connecticut, USA | Fairfield, Connecticut, USA | Hartford, ... values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our San Diego, ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical and economic decision-making… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ensuring ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties Act as the Global Regulatory … more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our ... in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, … more
- Bausch Health (Bridgewater, NJ)
- Associate Director , Regulatory Affairs Job Location: Hartford, Connecticut, USA | NewHaven, Connecticut, USA | Stamford, Connecticut, USA | Atlanta, Georgia, USA ... your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and post-approval/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Kyowa Kirin North America (Princeton, NJ)
- …in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion Compliance will ... for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director ...US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA… more
- Pall (Miami, FL)
- …innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- NVA (Pleasanton, CA)
- …medical leadership for the hospital, managing Associate Veterinarians, and assuring regulatory compliance relating to the practice of veterinary medicine. The ... Managing Veterinarian is also responsible for creating an environment of teamwork in which quality medicine and exceptional client service are delivered. In partnership with the Hospital Manager, the Managing Veterinarian is responsible for the financial… more
- Leica Biosystems (Miami, FL)
- …driving innovation and excellence in the Biopharma sector.This position reports to the Director , Regulatory Affairs and is part of the Global Regulatory ... about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and… more
- Gilead Sciences, Inc. (San Mateo, CA)
- …their aspirations. Join Gilead and help create possible, together. Job Description Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic...acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information… more
- Webster Bank (Stamford, CT)
- …search of a knowledgeable and experienced individual with understanding of US Regulatory Reporting. The candidate will be responsible for understanding various ... regulatory reporting needs for a category 4 bank and...Key Responsibilities include: Lead and coordinate analysis of various regulatory reporting needs for the bank. Collect and analyze… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
