- 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
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an...are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated… 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
- Organon & Co. (Sacramento, CA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... in the US + There are **2 openings** The Director , Clinical Pharmacology Lead will be responsible for contributing...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… 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