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Vice President Regulatory Affairs

Meet
Sunnyvale, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/15/2025

Vice President, Regulatory Affairs

Hybrid Workstyle (2-3x per week onsite in South San Francisco, CA)

Meet has partnered with an exciting biotech that is looking for a Vice President of Regulatory Affairs to join their team. Our client is focused in developing treatments for hematological and immunologic diseases. They are well-funded and are currently managing multiple clinical-stage program for first-in-class treatments.

Key Responsibilities

  • You will serve as the direct point of contact with the FDA and ex-US Health Authorities in support of regulatory submissions.
  • You will provide regulatory guidance in cross-functional discussions in support of product development and clinical development strategies.
  • You will lead the preparation of key regulatory submissions (IND / CTA / BLA / MAA)

Key Qualifications

  • 15 years of Regulatory Affairs experience
  • Experience leading BLA submission highly preferred
  • Small biotech experience highly preferred
  • Experience in autoimmune / hematology highly preferred
  • Please reach out to Ryan Moran if you're interested in learning more :

    ryan.moran@meetlifesciences.com

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