- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead (Director) **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of ... 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 (Framingham, MA)
- **Job Title:** GRA CMC Project Lead **Location:** Morristown, NJ Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on ... behaviours that live and promote the Sanofi Take the Lead behaviours and GRA Values/Principles/Competencies. We are...manufacture, or testing + Experience with combination (drug / device ) products + Proficient in MS Word, Excel, PowerPoint,… more
- J&J Family of Companies (Raritan, NJ)
- …successful negotiations of strategies and execution. **Major Duties & Responsibilities** + Effectively lead the vision and strategy for the GRA Dx function to ... maximize business opportunity + Lead the GRA Dx team for all global regulatory activities associated...strategy, registration and maintenance of new and approved medical device products across J&J Innovative Medicine (JJIM) TAs. +… more
- Lilly (Indianapolis, IN)
- …The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies ... requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA -CMC, GRA -Devices, and regional regulatory… 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
- Pfizer (Kalamazoo, MI)
- …Supply (PGS), Worldwide Research and Development (WRD) and Global Regulatory Affairs ( GRA ) teams to develop strategies on new product introduction for diverse new ... relevant pharmaceutical experience, particularly in Aseptic operations and Medical Device /Combination Products + Demonstrated success in planning, implementing, and… more