- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as ... the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Merck & Co. (South San Francisco, CA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Pfizer (San Diego, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. All… more
- Stryker (Sacramento, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in… more
