Executive Director, Global Regulatory Affairs CMC Early Development

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones.

Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development, analytical, formulation, drug substance/drug prod...