- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will ... programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial,… more
- Sanofi Group (Cambridge, MA)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and ... of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and...is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine … more
- J&J Family of Companies (Cambridge, MA)
- …quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical supplies unit, medical writing, clinical ... Director , Project Responsible Physician - Neuroscience - 2406186566W...Committee (IDMC) and adjudication meetings as needed. + Assists Regulatory Affairs in determining requirements for any… more
- Edwards Lifesciences (Boston, MA)
- …for Medicare Services (CMS) and/or Medicare Administrative Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers. **The Director , Global Health ... us and be part of our inspiring journey. The Director , Global Health Economics and Reimbursement is a field...with various internal business partners (especially Sales, Marketing, Clinical, Regulatory , Legal, and Government Affairs staff) to… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we… more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... (N) Department Office Location:USA - MA - Boston Business Title: Regulatory and Compliance ManagerSub-Unit: Appointment End Date:31-Jul-2025Salary Grade (https://hr.harvard.edu/salary-ranges#ranges)… more
- Boston University (Boston, MA)
- …Responsibilities include work on developing new educational initiatives with the Regulatory Education Manager and Director . Current educational initiatives ... The Regulatory Coordinator will contribute to the regulatory /ethics/IRB submission consultations process, ongoing educational initiatives, and Research… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, The Senior Director … more