- Revolution Medicines (Redwood City, CA)
- …pathway. The Opportunity: This position is responsible for developing and implementing CMC regulatory strategies. The role involves coordinating and preparing ... of RevMed's pipeline compounds/products. Responsibilities: Develop, lead, and implement global CMC regulatory strategies to support the clinical development… more
- Gilead Sciences, Inc. (Foster City, CA)
- A leading biopharmaceutical company in California seeks an Associate Director in CMC Regulatory Affairs to lead regulatory strategy and ensure ... have over 10 years of experience and proven success in executing CMC strategies. Strong leadership and communication skills are essential. Competitive salary range… more
- Revolution Medicines (Redwood City, CA)
- A precision oncology company is seeking a CMC Regulatory Strategist to develop and implement global regulatory strategies. The role involves leading ... regulatory submissions and ensuring compliance with quality standards. Candidates should have over 10 years of drug development experience and strong communication skills. This position offers an opportunity to make a significant impact on innovative… more
- Cytokinetics (San Francisco, CA)
- Associate Director , Toxicology page is loaded## Associate Director , Toxicologylocations: South San Francisco, Californiatime type: Full timeposted on: ... and collaborative individuals who are driven to make a positive impact.**Job purpose**As the Associate Director of Toxicology, you will play a critical role in… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... analytical deliverables. Serve as an author and reviewer of CMC sections in regulatory filings and support...Job Requisition ID R0049014 Full Time/Part Time Full-Time Job Level Associate Director Remote Type Onsite Required… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing… more
