Associate Director, US Regulatory Affairs Strategy

4 days ago


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

Transforming Healthcare through Innovative Regulatory Strategies

Daiichi Sankyo, Inc. is a global pharmaceutical innovator dedicated to creating and supplying cutting-edge therapies to improve healthcare standards worldwide. With a rich legacy of innovation spanning over 100 years, our team is committed to addressing unmet medical needs through world-class science and technology.


Key Responsibilities

  • Develop and implement effective US regulatory strategies for assigned projects, ensuring timely and quality submissions to regulatory agencies.
  • Lead and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, and orphan drug applications.
  • Collaborate with global product teams to provide regulatory support and guidance, managing day-to-day regulatory activities.
  • Review and interpret regulatory guidelines, staying up-to-date with the latest regulations and guidance documents.
  • Continuing Education: Attend meetings, seminars, conferences on relevant topics, read journals, newsletters, and scientific papers to stay current with regulatory developments.

Qualifications

  • 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.
  • Experience in (s)NDA/BLA filing to FDA preferred.

Travel

Ability to travel up to 20% for occasional global meetings and conferences.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.



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