- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... 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
- Oura (San Francisco, CA)
- …do their best work - both in and out of the office. We are looking for a Director , Regulatory Affairs and Quality Assurance to play a key role in shaping ... on our team if you have: + Bachelor's degree in life sciences, engineering, regulatory affairs , or a related field; advanced degree preferred. + 8+ years of … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Associate Director , CMC Regulatory Affairs for Biologics is ... approval process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Responsible for development of regulatory… more
- Gilead Sciences, Inc. (Foster City, 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 partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience or 10 + years… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... enterprise platforms. + Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. + Translate… more
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