Director of Regulatory Affairs and Strategy

3 weeks ago


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

We are seeking a highly skilled Director of Regulatory Affairs and Strategy to join our team at Daiichi Sankyo, Inc.

About the Role

This is a leadership position responsible for providing strategic and tactical regulatory guidance across our alliance products. The successful candidate will be accountable for developing and implementing effective regulatory strategies, preparing and submitting high-quality FDA documents, and leading cross-functional teams to achieve regulatory milestones.

Key Responsibilities
  • Develop and execute regulatory plans for assigned projects, ensuring timely and compliant submissions to the FDA.
  • Lead and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, and BLA annual reports.
  • Collaborate with internal stakeholders to obtain and provide critical information for regulatory filings.
  • Strategize and plan for FDA meetings, liaising and negotiating with regulatory agency representatives.
  • Mentor and guide direct reports in the development of robust and innovative regulatory strategies.
Requirements
  • Bachelor's degree in chemistry, biology, or related field required; advanced degrees preferred.
  • At least 10 years of experience in the pharmaceutical industry, with 7+ years in regulatory affairs.
  • Experience with US regulatory affairs from IND through NDA/BLA required.
Salary and Benefits

The estimated salary range for this role is $180,000 - $220,000 per year, depending on experience. Additionally, Daiichi Sankyo, Inc. offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

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 collaborative team culture.



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