- Sanofi Group (Swiftwater, PA)
- **Job Title:** GRA CMC Lead **Location** : Swiftwater, PA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on to ... GRA . + Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product… 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 ... ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of medicine? The ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development....function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination… 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 ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development....projects with the diagnostics and/or combination product platform regulatory lead (s). The role will represent the GRA … more
- Lilly (Indianapolis, IN)
- …people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ( GRA - CMC ) leads and manages the scientific and regulatory ... in regulatory practices, operational efficiency, and personnel development within the GRA - CMC organization. **People Excellence - Supervision of Personnel** +… more
- Lilly (Indianapolis, IN)
- …affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA - CMC , GRA -Devices, and regional ... of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative... Global Regulatory Team consisting of regional regulatory scientists, GRA - CMC , GRA -Devices, GRA -RD&E,… more
- Lilly (San Francisco, CA)
- …Team + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA - CMC , GRA -Devices, GRA -RD&E, and GRA -Global Labeling ... of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative...GRL is the primary interface with, and will represent GRA on global brand development/program team to ensure global… more
- Amgen (Washington, DC)
- …of patients while transforming your career. **Regulatory Affairs Director - Global Regulatory Lead ** **What you will do** Let's do this. Let's change the world. ... Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs ( GRA ) provides global regulatory leadership, expertise, and execution for the… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the ... and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches… more
- Amgen (Washington, DC)
- …supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs ( GRA ) provides global regulatory leadership, expertise, and execution for the ... management of all Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The… more