Senior Director, US Regulatory Affairs Strategic Alliance Leader

3 weeks ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
About Daiichi Sankyo

Daiichi Sankyo Group is a global pharmaceutical innovator with a rich legacy of innovation. With over 125 years of scientific expertise and a presence in more than 20 countries, the company is dedicated to creating and supplying innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs worldwide.

Job Summary

This Senior Director role is responsible for providing regulatory strategic leadership and alignment on assets subject to an alliance. The successful candidate will lead regulatory strategy development, coordinate preparation of US regulatory submissions, and provide US regulatory support to ensure timely and quality submissions to the FDA.

Key Responsibilities
  • Develop and implement US regulatory strategies for assigned projects, including leading and preparing FDA submissions such as briefing documents, breakthrough therapy designation requests, orphan drug applications, and BLA annual reports.
  • Collaborate with cross-functional teams within Daiichi Sankyo to obtain and/or provide information/data for regulatory filings.
  • Liaise, negotiate, and orchestrate meetings with FDA, and prepare internal meeting minutes for archiving.
  • Serve as a US RA strategy SME, coordinating, mentoring, and providing guidance to direct reports across alliance products to produce robust, innovative, and cohesive regulatory strategies/plans.
  • Establish clear and consistent ways of working across the alliance regarding work impacting US regulatory affairs.
Requirements

The ideal candidate will possess a Bachelor's Degree in chemistry, biology, or a related discipline, and have at least 10 years of experience in the pharmaceutical industry, with 7+ years in regulatory affairs, specifically in US regulatory affairs from IND through NDA/BLA.

Compensation and Benefits

The estimated salary range for this position is $160,000 - $220,000 per year, depending on qualifications and experience. Daiichi Sankyo offers a comprehensive benefits package, including health insurance, retirement savings plan, paid time off, and professional development opportunities.



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