Director, Japan CMC & Devices Regulatory Affairs, New Drug Application Group
TakedaOsaka, Japan • Japan
Posted October 23, 2025
Full Time
About the Company
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities. Read our community guidelines: https://takeda.info/communityguidelines
Job Description
Lead the Japan CMC & Devices RA New Drug Application group to fulfill expected roles and responsibilities. Oversee regulatory CMC development and registration strategies, communicate with Health Authorities, and demonstrate leadership and regulatory expertise.
Requirements
- Lead a group of individuals to support group’s goals
- Oversee the development and execution of regulatory CMC development and registration strategies
- Successfully communicate and negotiate with Health Authorities
- Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines
