- 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
- BeiGene (San Mateo, CA)
- **General Description:** Sr . Manager/Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Purification Process Development - Pivotal & Commercial ... Biologics** The Senior Director of Purification Process Development for...strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC , and Manufacturing. + Lead… 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 ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical 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
- BeiGene (San Mateo, 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