- Formation Bio (New York, NY)
- …and preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC , Regulatory Affairs , Clinical Operations) to ensure alignment ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination and execution ... marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Boehringer Ingelheim (Ridgefield, CT)
- …supplemented by internal BI capabilities. + Oversee the preparation and submission of CMC regulatory documents, including INDs, NDAs, and BLAs. + Collaborate ... **Description** The Director of CMC Project Management in...with internal and external stakeholders, including R&D, Quality, Regulatory Affairs , and Manufacturing, to ensure seamless… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on clinical regulatory issues and filings but could include ... issues. With regard to these matters, the Senior Director will provide strategic as well as regulatory… more
