- 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
- 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
- AbbVie (South San Francisco, CA)
- …drug development, such as Discovery, Preclinical Development, Clinical Development, Process Development, CMC , or Regulatory Affairs . Must possess solid ... a major revenue driver for the company. The Senior Director , Search & Evaluation will lead the Oncology S&E...President, Search & Evaluation and Global Alliances, the Senior Director , Search & Evaluation Oncology will have strong working… more