GRA CMC Director - Marketed Products Development Lead
TakedaZurich, Zurich, Switzerland
Posted December 9, 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
As a Director, Global Regulatory Affairs CMC Marketed Products Development (MPD) Lead, you will be accountable for developing and executing on GRA CMC strategies for lifecycle management. You will lead a team and ensure their effectiveness in a complex matrix environment.
Requirements
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 10+ years pharmaceutical Regulatory CMC experience
- Experience with active pharmaceutical ingredient/drug substances, small molecules, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products
- Expert in developing alternate strategies based on guidance/regulations
- Expert in liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
- Ability to deal with issues of critical importance and make reasoned decisions on regulatory issues
- Demonstrate leadership, problem-solving ability, flexibility, and values teamwork
- Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues
- Good judgement in elevating and communicating actual or potential issues to line management
- Expert in CTD authoring and/or review skills throughout the product lifecycle