- Abbott (Milpitas, CA)
- …Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers + Coordinates across functional ... of entire medical device development process from needs definition through regulatory approvals, production, launch, and product life cycle maintenance. + Proven… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Deviations, CAPAs, Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with ... regulatory communications as needed (eg responses to agency information...+ 8+ years of relevant experience and a PharmD, PhD , in science or related fields OR + 8+… more
- Astellas Pharma (South San Francisco, CA)
- …and transfer reports and SOPs. + Keep current with all regulatory guidelines, compendia requirements, work related publications and technical innovations. + ... + This position requires onsite work. **Required Qualifications:** + PhD with 3+ years, or MS with 8+ years,...project teams to enable decision making and writing for regulatory filings. + Success in development and transfer of… more
- AbbVie (South San Francisco, CA)
- …of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development ... including study design, and clinical pharmacology strategy. + Author regulatory documents including protocols, study reports, population PK reports,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate across Gilead ... Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for HCV. + Ensure compliance with all applicable laws, regulations, and regulatory guidelines governing commercial and scientific interactions with payers and other ... + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven cross-functional… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay abreast of the latest ... and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more
- Ascendis Pharma (Palo Alto, CA)
- …to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions + Maintain up-to-date knowledge of relevant science, medical ... information, good clinical practices, and regulatory guidance + Collaborate with-and serve as a clinical research resource for-cross-functional colleagues to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This ... collaboration at the Team Leadership level with the Development, Quality, Regulatory , Analytical, Supply Chain, and Product & Portfolio Strategy organizations within… more