- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of medicine? ... affairs ( GRA ) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination Products will oversee key regulatory… more
- Sanofi Group (Cambridge, MA)
- **Job title** : GRA Device Lead (Associate Director) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... be critical in helping our teams accelerate progress. The GRA Device team is a globally diverse...regulatory lead (s). The role will represent the GRA Device perspective as a member of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products ... global regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares...(MS), with Ph.D. preferred. + 15+ years of seasoned biopharmaceutical/ device industry experience or with a regulatory agency, while… more
- Takeda Pharmaceuticals (Boston, MA)
- …the development, maintenance, and implementation of Instruction for Use (IFU) documents and Device Container Labeling content in line with US and EU standards and ... while ensuring compliance with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global … more