- MannKind Corp. (Burlington, MA)
- …regulatory leadership team and are seeking a strategic, execution‑oriented Associate Director of Regulatory Strategy with a strong foundation in ... CMC, clinical, and operations. Responsibilities Define & Drive Global Strategy : Serve as the global regulatory lead...Drive Global Strategy : Serve as the global regulatory lead for assigned development programs and marketed products,… more
- Alkermes, Inc. (Waltham, MA)
- A leading biopharmaceutical company is seeking an experienced Associate Director for Regulatory Affairs CMC to provide strategic regulatory direction and ... 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
- MannKind Corp. (Burlington, MA)
- A biopharmaceutical company is seeking an Associate Director of Regulatory Strategy . The role involves leading regulatory strategy for ... across development stages. Candidates should have a strong background in regulatory affairs, including experience with FDA interactions and global submissions. Ideal… 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
- Real Staffing (Boston, MA)
- …leading staffing organization is seeking an experienced Associate Director of Regulatory Affairs to support regulatory strategy on a contract basis. ... role offers flexible remote or hybrid options and involves leading regulatory submissions and maintaining compliance with global health authorities. Candidates… 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 ... are seeking an experienced and strategic Associate Director / Director of CMC Regulatory Affairs...Module 3 CMC information for partner submissions. Key Responsibilities Regulatory Strategy & Leadership Develop and implement… more
- Madrigalpharma (Waltham, MA)
- Associate Director , Regulatory Affairs, Advertising and Promotion page is loaded ** Associate Director , Regulatory Affairs, Advertising and ... in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.The Associate Director , Regulatory Affairs, Advertising and Promotion is responsible… 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 … more
- Gilead Sciences, Inc. (Foster City, CA)
- Position Associate Director , CMC Regulatory Affairs - Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, ... of Gilead, you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more products. Lead the execution and… more
- AstraZeneca (Boston, MA)
- Job Title: Clinical Regulatory Writing Manager ( Associate Director ) Location: Boston, MA - Hybrid Introduction to role Are you ready to be part of the ... solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory ...efficiency. Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead. Lead… more
