- Vera Therapeutics (Brisbane, CA)
- …team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working with the cross-functional team ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , Global Clinical Supply Chain - Inflammation/MAP** **KEY ... RESPONSIBILITIES:** Senior Director , Global Clinical Supply Chain is...Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory , and Project Management Office - to develop and… more
- BeiGene (San Mateo, CA)
- …Will work cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide ... in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. The role...and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate with the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development… more
- BeiGene (San Mateo, CA)
- …with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory , CMC etc. Responsibilities will include planning and reviewing ... **General Description:** The Director , Clinical Pharmacology & Pharmacometrics will be responsible...and authoring and defending the clinical pharmacology sections of regulatory filings. A working knowledge of global regulatory… more