- Jazz Pharmaceuticals (Palo Alto, CA)
- …strategy, which integrates scientific rationale, clinical development, nonclinical development, regulatory , medical, commercial input, CMC , legal and other ... a focus on deep science and innovation, with speed and potential program and regulatory uncertainty or risks as well as maximizing over value for our patients. The… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr Director , CMC Regulatory Affairs -Small Molecules** ... **KEY RESPONSIBILITIES** The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with… 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)
- …headquarters 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
- BeiGene (Emeryville, 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
- 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 will be responsible for developing...and authoring and defending the clinical pharmacology sections of regulatory filings. A working knowledge of global regulatory… more
- BeiGene (Emeryville, CA)
- …position will have oversight for supporting functional areas such as Regulatory Affairs ( CMC , Strategy, Project Management), Quality/Manufacturing, Clinical, and ... + This position will interact at all levels, including BeiGene's Senior Management, responsible for creating, reviewing and/or approving submission dossiers for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …role in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible ... with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by… more
