Global Regulatory Affairs Director

1 day ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

Job Summary

Daiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities

  • Liaise with FDA and other regulatory agencies to ensure timely and quality submissions.
  • Prepare and publish regulatory documents, including NDAs, INDs, and Annual Reports.
  • Participate in global product team meetings and provide regulatory support and guidance.
  • Collaborate with cross-functional teams to obtain and provide information/data for regulatory filings.
  • Mentor and instruct direct reports and review and interpret regulatory guidelines.

Requirements

  • Bachelor's Degree required; advanced degree preferred.
  • 7+ years of experience in the pharmaceutical industry, with 4+ years in regulatory affairs.
  • Ability to travel up to 30%.

About Daiichi Sankyo, Inc.

We are an equal opportunity/affirmative action employer and value diversity and inclusion in the workplace. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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