- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development. The selected candidate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to ... to steady supply of Clinical Trial Materials (CTM). **Responsibilities** + Lead the authoring, revising, and managing the day-to-day activities associated with… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, ... innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee submission planning, authoring,… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling content and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …key strategic questions that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director , Development to Launch Analytics, ... to proactively identify and address priority business questions related to CMC development, new product introduction and business operations. This includes all… more