- 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)
- …on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies ... manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + Represents and… more