CMC Regulatory Strategy Director

5 days ago


Dubai, Dubai, United Arab Emirates ClickJobs Full time
CMC Regulatory Strategy Director Job Description

This is an exciting opportunity to join our team as a Manager, Global Regulatory Affairs CMC in Cambridge, MA.

About the Role

The successful candidate will be responsible for developing and implementing regulatory strategies for commercial and development phase products.

  1. Developing regulatory submission strategies for products in commercial and development phases by working in close coordination with the quality, manufacturing, and global regulatory teams;
  2. Ensuring timely responses to health authority queries by working with regulatory teams across different regions;
  3. Submitting compliance submissions such as annual reports, yearly biologic periodic reports, and license renewals in a timely manner to ensure marketed products comply with Health Authority requirements;
  4. Providing regulatory assessments for change controls for various markets, including US FDA, EMA, and Health Canada, as well as liaising with in-country regulatory representatives to provide these assessments.
About Takeda

Takeda Development Center Americas, Inc. is a leading pharmaceutical company that offers a dynamic work environment with opportunities for growth and development.



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