- Gilead Sciences, Inc. (Foster City, CA)
- …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- Deloitte (San Jose, CA)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Vera Therapeutics (Brisbane, CA)
- …assessment of process capabilities. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. * Participate in vendor selection ... manufacturing. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality documents. The… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer Skills**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional ... this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …in a highly collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In ... in a highly collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners.… more