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Executive Director, Regulatory Affairs

Trebla Talent
San Jose, CA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/20/2025

Role : Senior Director / Executive Director of Regulatory Affairs

Location : Bay Area (Remote - West Coast Preferred)

About the Company :

This late-stage clinical biotech is pioneering a new class of complementary medicines for patients battling neurodegenerative and autoimmune disorders. The company is expanding its regulatory team following groundbreaking positive data from its successful Phase 3 trial.

The Role :

With exciting plans to file its first BLA in 2025, the team is naturally expanding! This ED / SD will report to the Head of Regulatory Affairs and provide strategic regulatory leadership for its upcoming BLA submission and additional NDA / MAA submissions.

  • Lead NDA and MAA Regulatory Strategy while supporting the ongoing BLA
  • Directly interface with FDA and EMA.
  • Make hiring decisions as the Regulatory team expands

What We're Looking For :

  • 15 years of industry experience across Regulatory Affairs and Strategy
  • Hands-on experience supporting and / or leading BLAs or NDAs
  • Prior experience leading, managing, and developing late-stage clinical programs.
  • Rare Disease, Neurology or Autoimmune experience preferred.
  • If you are interested in the Executive Director of Regulatory Affairs, please reach out to Dakota.Lowe@treblatalent.com.

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