- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ... Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others. As GRA Device Lead in the GRA Device Digital and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Associate **Location:** Cambridge, MA/ Morristown, NJ/ Washington DC **About the Job** Are you ready to shape the future of medicine? ... portfolio of products. The team is part of the GRA CMC & GRA Device ...Contribute to device Health Authority interactions plan, lead device related health authority interactions and… 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 (Boston, MA)
- …regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to ... global regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares...(MS, Ph.D., etc.) required. + 10+ years of overall biopharmaceutical/ device industry experience with 8+ years pharmaceutical Regulatory CMC… more
- CSL Behring (King Of Prussia, PA)
- …plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk assessment and decision making. Ensures bi-directional ... communication with stationed region commercial operations and GRA . With support, engaging with health authority (HA) in stationed country (FDA or EMA), maintaining… more
- Sanofi Group (Morristown, NJ)
- …impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs ( GRA ) CMC & Device Organization serves as a critical strategic ... expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our department bridges the… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs ( GRA ) professional is responsible for developing and executing global regulatory ... renewals, variations) around small molecule drug substance, drug products and drug- device combination products. Ensure compliance with global regulations (FDA, EMA,… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …that may impact pharmaceutical practices, procedures and controlled documents. + Lead weekly regulatory intelligence team meetings to include review and discussion ... maintain optimal functioning of the regulatory intelligence technology platform. + Lead internal process to obtain, coordinate, and document cross-functional SME… more