Regulatory Affairs Strategy Director

2 days ago


Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

Legacy of Innovation

Daiichi Sankyo Group is dedicated to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000 employees draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.


Key Responsibilities

  • Develop and implement effective regulatory strategies to deliver on efficient and robust development plans.
  • Direct, coordinate, and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects.
  • Meet aggressive deadlines to ensure timely and quality submissions to regulatory agencies, shortening the review process and leading to successful approval of pharmaceutical applications.

Requirements

  • Bachelor's Degree in chemistry, biology, or other related scientific discipline required.
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred.
  • 4 or More Years in the pharmaceutical industry preferred.
  • 1 or More Years in regulatory affairs required.

Travel

Ability to travel up to 20%. In-house office position that may require occasional travel (global).



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