- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...operate" by maintaining the global licensures. In addition, the Sr Director will be accountable for leading… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The Sr Director , Analytical ... to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading...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
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in **Foster City, California.** ** Senior Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** ... in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional… 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
- Ascendis Pharma (Palo Alto, CA)
- …information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... to all aspects of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will be responsible for supporting and developing… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …The Director role in the Analytical Development organization reports to the Senior Director of Analytical Development and is a leader in analytical method ... with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by… 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
- 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