- 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 (Lexington, MA)
- …manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + Represents and ... identified for US Medical activities are reported up through to the Program Manager and Medical and Scientific. + Independently resolves complex issues and competing… more
- ManpowerGroup (Andover, MA)
- …your contribution will directly impact patients. You will achieve A project manager role is available within the Biotherapeutics Portfolio & Strategy group in ... early and late stage product development teams inclusive of CMC regulatory submission support. Early phase support will include...and sub teams. . In both cases, the project manager will be responsible for assisting in the coordination… more