- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of ... products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development. Sanofi's global regulatory… more
- AbbVie (Worcester, MA)
- …strategic programs; including Brand Teams, New Product Introductions, Product Transfers, CMC , Global Strategic Sourcing, Due Diligence, Site Selection, and Approvals ... and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections. Qualifications + Bachelor's Degree in relevant Life Science or other technical required. Graduate degree… more
- Fresenius Medical Center (Waltham, MA)
- …into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, updates, and ... guidance from global agencies, ensuring the company's strategies remain aligned with changing regulatory requirements. + Cross-Functional Collaboration & Stakeholder Management: + Serve as a regulatory contact for cross-functional teams, ensuring alignment on… more
- Humana (Boston, MA)
- …mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, by ensuring compliance with governmental requirements for ... pharmacy knowledge a plus + Certified Coder (CPC, CRC, and/or CMC ) + Experience with metrics and reporting **Additional Information** **Work-At-Home Requirements:**… more
- Shuvel Digital (Boston, MA)
- …Has supervisory and developmental responsibilities within a functional area. The program director manages one or more projects or programs, may manage an operating ... ITIL Certification (Information Technology Infrastructure Library) + Certified Management Consultant ( CMC ) + Leadership in Energy and Environmental Design (LEED) +… more