- Vir Biotechnology, Inc. (San Francisco, CA)
- …Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned ... products have a successful regulatory CMC strategy for clinical development and...health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director /Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... Manufacturing, Supply Chain, and Quality; and assist in ensuring regulatory compliance. The Director /Sr will be responsible...be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of… more
- San Francisco (San Francisco, CA)
- …THE ROLE Reporting to the Vice President, CMC Operations, the Head of/ Senior Director CMC Operations (Drug Substance) will manage activities related ... Drug substance. Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug… more
- Indapta Therapeutics Inc. (San Francisco, CA)
- …The Position: Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, excitement, ... moving from early to later phase clinical trials. Responsibilities will include: Lead the CMC QA function and partner with clinical, regulatory and CMC … more
- Ascendis Pharma A/S (Palo Alto, CA)
- …and those of direct reports. Work is performed under direction of a Senior Regulatory Affairs professional. Contribute to internal regulatory policies ... offer a dynamic workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for developing and implementing… more
- Rezolute (Redwood City, CA)
- The Senior Director , Global Supply Chain will...and EU.The individual will work amongst a team of CMC experts in a matrix organization, capitalizing on each ... technical communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant...RespectRezolute (RZLT) currently anticipates the base salary for the Senior Director , Global Supply Chain role could… more
- 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...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… 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
- 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
- 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
- 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
