- 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 (Emeryville, 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
- 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
- Surrozen (South San Francisco, CA)
- …with multidisciplinary teams including preclinical development, biostatistics, clinical operations, quality, regulatory affairs and CMC . As leader of ... AMD/uveitic macular edema (UME). Reporting directly to the CEO, the Exec. Director /VP Clinical Development will contribute to and lead early clinical programs in… 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