- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
- BeOne Medicines (San Mateo, CA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Lilly (San Francisco, CA)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...across multiple countries + Direct experience in clinical and CMC regulatory sciences + Knowledge of Global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... Gilead and help create possible, together. **Job Description** The Director in Biologics Analytical Development (Pivotal and Commercial) will...strategies + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Vera Therapeutics (Brisbane, CA)
- …regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams * Evaluate proposed ... * Experience communicating regulatory strategies to stakeholders * Demonstrated Regulatory Affairs experience commensurate with the role * Industry… more
- AbbVie (San Francisco, CA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and… more