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Regulatory Affairs Director

2 months ago

Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time
Unlock Your Potential in Regulatory Affairs

Daiichi Sankyo Group is a pioneering pharmaceutical company dedicated to delivering innovative therapies that improve patient outcomes. As a key player in the industry, we're committed to pushing the boundaries of science and technology to address unmet medical needs.

About the Role

We're seeking an experienced Associate Director, US Regulatory Affairs Strategy to join our team. In this critical role, you'll be responsible for developing and implementing effective regulatory strategies to drive the success of our cutting-edge assets. Your expertise will be instrumental in navigating the complex regulatory landscape and ensuring timely and quality submissions to the FDA.

Key Responsibilities

  • Develop and execute US regulatory strategies for assigned projects, ensuring alignment with global product teams.
  • Liaise and negotiate with FDA representatives to secure successful outcomes for our products.
  • Prepare and submit high-quality regulatory documents, including briefing documents and orphan drug applications.
  • Collaborate with cross-functional teams to obtain and provide critical information for regulatory filings.
  • Stay up-to-date with regulatory guidelines and best practices, applying this knowledge to drive regulatory excellence.

Requirements

  • Bachelor's degree in a relevant scientific discipline, with advanced degrees preferred.
  • Minimum 4 years of experience in the pharmaceutical industry, with 1+ years in regulatory affairs.
  • Proven track record of success in regulatory strategy and FDA interactions.

What We Offer

Daiichi Sankyo, Inc. is an equal opportunity employer committed to diversity and inclusion. We offer a dynamic work environment, opportunities for professional growth, and a competitive compensation package.