- 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 ... values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive… more
- Pfizer (San Diego, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or… 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
- 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 ....mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional ( United States… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... development, regulatory , and registration strategies within the US and Canada. The Director will also...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Stryker (Sacramento, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... best-in-class visualization and connectivity products to market in the United States , Canada and Europe. Through close...leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …grow and become your best self. Become a **maker of possible** with us . Director of Regulatory Affairs is responsible for developing and implementing ... US and international laws and regulations + Manage Regulatory Affairs platform and leads a team...four (4) years managerial experience + Comprehensive knowledge of United States , European, and international regulations and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …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
- GRAIL (Menlo Park, CA)
- …position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, ... projects, including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs),… 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 ... or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
