- Sanofi Group (Framingham, MA)
- **Job title:** _GRA CMC Lead_ + _Location: Morristown, NJ_ **About the Job** As GRA CMC Lead within our GRA CMC & GRA Device Organization, ... to get started? Within Sanofi's Global Regulatory Affairs ( GRA ) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to ... 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 (Cambridge, MA)
- **Job Title:** GRA Device Lead (Associate Director) - Digital...portfolio of products. The team is part of the GRA CMC & GRA Device Department ... Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead (Associate Director) - Digital Health Are you ready to shape the future of… more
- Sanofi Group (Cambridge, MA)
- …diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA ... **Job Title:** GRA Device Associate **Location:** Cambridge, MA/ Morristown, NJ/...started? **Main Responsibilities** + Partner with the Device Regulatory Lead on assigned projects + Provide regulatory guidance and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs ( GRA ) professional...guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams… more
- Sanofi Group (Framingham, MA)
- … team member, ensuring data supports expedited pathways to clinic and patients + Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, ... of science to improve people's lives. **Main Responsibilities:** + Lead , coordinate, and manage CMC dossier preparation...submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and… more
- Takeda Pharmaceuticals (Boston, MA)
- …pipeline combination products, while bringing the current products to today's standards. + Represent CMC and GRA on key governance committees and play a critical ... (VP/SVP) in R&D (Discovery and Therapeutic area units - TAUs), GRA , GMS, Global Quality and Commercial. **Accountabilities:** + Develop innovative strategies… more
- Sumitomo Pharma (Boston, MA)
- …in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of ... Associate Director is part of the Global Regulatory Affairs ( GRA ) team based in the US. He/She will primarily...**Job Duties and Responsibilities** + As a Regional Regulatory Lead , manage regional (United States, European and/or ROW) regulatory… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- Parexel (Boston, MA)
- …compliance with country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University ... dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. * Lead impact assessments for technical and global labeling changes across… more