- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as well as ... we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy...of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR,… more
- Merck & Co. (South San Francisco, CA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational… more
- Pfizer (San Diego, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study… 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...to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical … more
- GRAIL (Menlo Park, CA)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs , quality, or program management ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology, or… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical...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 ... Canada and Europe. Through close partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop… 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 ... an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Medical Affairs (Facial Aesthetics Portfolio and Bodycontouring) ... Medical Affairs , in partnership with key Medical functional units, the Director , Medical Affairs will support development of a comprehensive medical strategy… more
