- AbbVie (Waltham, MA)
- …8, Masters with 6, or PhD with 3 years of CMC biologics functional experience. + Senior Manager : Bachelors with 10, Masters with 8, or PhD with 5 years of ... that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC ...with CMC teams during the development of CMC control strategies. Implement well-defined, efficient processes for preparation… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. At ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Sanofi Group (Waltham, MA)
- …per department/platform, per strategic direction and in agreement with senior leadership. Ensure ongoing activities are resourced effectively and efficiently, ... 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… more