- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, ... R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The CMC Project Manager is a key contributor of the CMC … more
- Parexel (Providence, RI)
- …options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager ** to join a growing, dedicated client ... regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best...3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- Shuvel Digital (Boston, MA)
- …Certifications + IT and Technology-Specific Certifications + Certified Information Systems Project Manager (CISPM) + ITIL Certification (Information Technology ... Project /Program Manager Boston, MA - Hybrid... Project /Program Manager Boston, MA - Hybrid (Remote and In...Infrastructure Library) + Certified Management Consultant ( CMC ) + Leadership in Energy and Environmental Design (LEED)… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Sanofi Group (Waltham, MA)
- …Links with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… more
- Takeda Pharmaceuticals (Boston, MA)
- …The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance… more
- Sanofi Group (Waltham, MA)
- …and assessment of new vaccine opportunities. + Work with Function LT and Headcount manager in support of the department to manage headcount targets approved by R&D ... knowledge of value chain and key contributing functions + Experience in project & resource management is essential + Strong analytical, synthesis and reporting… more