- 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)
- …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
- Gilead Sciences, Inc. (Foster City, CA)
- …maintenance of licenses. + Work is performed with no immediate direction from a senior Regulatory Affairs professional. + Is recognized as a knowledgeable ... & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience.... requirements up to date and communicate changes in regulatory information to project teams and senior … more
- Gilead Sciences, Inc. (Foster City, CA)
- … of the HIV Treatment Strategy team. We are looking for a highly motivated Medical Affairs Senior Director who has a strong background in HIV Treatment. They ... their aspirations. Join Gilead and help create possible, together. **Job Description** The Senior Director (SD) USMA Strategy - HIV will serve an important… more
- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… 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)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior...Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
- BeOne Medicines (Emeryville, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- Genentech (South San Francisco, CA)
- …part of a thriving culture built on collaboration and innovation. Job Summary The Senior Director , Therapeutic Area Analytics & Insights - Rare Diseases (RD) at ... AI empowers business partners across Commercial, Medical, and Government Affairs (CMG) to make impactful decisions by leveraging data,...and Business Development. As a key advisor to the Senior Leaders, the Senior Director … more
- Genentech (South San Francisco, CA)
- **The Position** **The Opportunity** The Sr. Medical Science Director / Sr. Medical Director will provide exceptional clinical and scientific leadership for ... medical affairs activities, aiming to generate and communicate medical evidence...Provide a medically sound and clinically meaningful perspective for regulatory and other scientific communications + Contribute to strategic… more