- Gilead Sciences, Inc. (Foster City, CA)
- Position Associate Director , CMC Regulatory Affairs - Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that ... you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more...Opportunities portal in Workday. Job Requisition ID R0047307. Full Time/Part Time: Full-Time. Job Level: Associate Director .… more
- Codexis, Inc. (Redwood City, CA)
- Associate Director / Director , CMC Regulatory Affairs Department: 58 - Tech Ops Management Employment Type: Full Time Location: Redwood City, CA ... $250,000 / year Description We are seeking an experienced and strategic Associate Director / Director of CMC Regulatory Affairs to lead and execute … more
- Alkermes, Inc. (Waltham, MA)
- A leading biopharmaceutical company is seeking an experienced Associate Director for Regulatory Affairs CMC to provide strategic regulatory direction ... related to a late-stage development program. The role requires expertise in regulatory compliance and the ability to collaborate with cross-functional teams. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Regulatory Affairs CMC Job Description We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit ... at our Foster City, CA site. Responsibilities: The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction,… more
- 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
- Dyne Tx (Waltham, MA)
- …X, LinkedIn and Facebook. Role Summary The Associate Director , Regulatory Chemistry Manufacturing and Control ( CMC ) is accountable for executing global ... CMC regulatory strategies for our programs in early and late-stage...as point of contact to cross-functional teams on global Regulatory CMC project/program issues Execute regulatory… 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
- Allergan (Greenlawn, NY)
- …in Germany, where your expertise will address tomorrow's unmet medical needs. As an Associate Director / Director CMC Product Development you independently ... regulatory queries, and participates in communications and meetings with regulatory agencies. Taking accountability for creating CMC development plan incl.… more
- The Antibody Society (Chicago, IL)
- …Germany, where your expertise will address tomorrow's unmet medical needs. As an Associate Director / Director , CMC Product Development, you independently ... to regulatory queries, and engaging in communications and meetings with regulatory agencies. Leading PPDST and/or CMC development teams for assigned… 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
- The Antibody Society (Chicago, IL)
- A leading biopharmaceutical organization in Chicago seeks an Associate Director / Director for CMC Product Development. The successful candidate will ... manage complex CMC programs, lead interdisciplinary teams, and ensure compliance with regulatory requirements. A qualification in a relevant scientific field and… more
- NWRPros (Palo Alto, CA)
- …gastroesophageal cancers. Our Client is seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ... ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory … more
- Crescent Biopharma, Inc. (Waltham, MA)
- …and follow the Company on LinkedIn and X. Position Overview The Associate Director , Regulatory Operations, will oversee the planning, ... Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs. Drive continuous improvement on all Regulatory submission… more
- MannKind Corp. (Burlington, MA)
- …growing our regulatory leadership team and are seeking a strategic, execution‑oriented Associate Director of Regulatory Strategy with a strong foundation ... (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC , clinical and combination product matters. Regulatory ...on CMC , clinical and combination product matters. Regulatory Planning & Submissions : Lead regulatory … more
- Vertex Pharmaceuticals (Boston, MA)
- …analytical activities that lead to successful IND/IMPD and/or BLA/MAA applications.* Authors CMC sections of regulatory submissions. Ensures that all regulated ... control strategy, design stability programs and comparability studies.* Experience authoring CMC sections of regulatory documents.* Experience of Regulatory… more
- Outpace Bio, Inc (Seattle, WA)
- …plug‑and‑play technology platform. Outpace Bio is seeking a highly talented and experienced Associate Director / Director of Translational Sciences to lead the ... be considered to align with company operations: CA, OR, or WA. This position is an Associate Director or Director level position with a compensation range of… 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
- Cedent Consulting Inc. (San Francisco, CA)
- Associate Director , Analytical Sciences (South San Francisco, CA) Client is seeking a highly motivated analytical research and development scientist with a ... record of sustained laboratory achievement and innovation to join their growing CMC group. The candidate will be part of cross‑functional teams providing analytical… more
- Madrigalpharma (Waltham, MA)
- Associate Director , Integration Engineer About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non‑alcoholic steatohepatitis ... for the treatment of NASH with compensated cirrhosis. Role Overview As the Associate Director of Integration Engineering, reporting to the Senior Director… more
- Cedent Consulting Inc. (Boston, MA)
- Associate Director , Analytical Development & QC (Boston, MA) The individual will lead the development, implementation, and improvement of internal QC systems for ... programs, including qualification/requalification, inventory, and bridging activities. Partner with CMC technical SMEs, QA and Regulatory to...Partner with CMC technical SMEs, QA and Regulatory to prepare and review QC related sections of… more
