GRA CMC Director - Marketed Products Development Lead

Description

– Director GRA CMC Marketed Products Development (MPD) Lead

Join Takeda as Director, Global Regulatory Affairs CMC Marketed Products Development (MPD) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management. You develop and execute on global strategies across the existing portfolio, lead a team, and ensure their effectiveness in a complex matrix environment. Reporting to the Head of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence, enhance prioritization, and strengthen communication and decision making processes.

How you will contribute:

Independently manage regulatory submissions for assigned compounds for global marketing applications, and post-approval life cycle activities.

Evaluate change proposals for global regulatory impact and plan global variations and amendments.

Member of global teams w...