Demo

Director of Regulatory Affairs

Meet
Hayward, CA Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/11/2025

Director, Regulatory Affairs

Hybrid Opportunity - 2-3x per week onsite in South San Francisco, CA

Meet has partnered with a clinical-stage, pre-IPO biotech focused in treatments for rare hematology / oncology indications. They are looking for a Director of Regulatory Affairs to join their team!

Key Responsibilities

  • You will report into the SVP of Regulatory Affairs and will provide regulatory guidance / support for multiple clinical-stage programs.
  • You will work with cross-functional leaders to support the planning and preparation of Phase III protocols and BLA submissions.
  • You will work with CRO's / consultants in ex-US countries (EU / UK) in support of CTA and MAA preparation

Key Qualifications

  • 8 years of pharmaceutical regulatory affairs experience required
  • Experience in hematology / oncology / autoimmunity highly preferred
  • Leading programs from Phase I through NDA / BLA submission highly preferred
  • Experience liaising with EMA / MHRA to facilitate CTA / MAA submissions preferred
  • Please reach out to Ryan Moran for more information :

    ryan.moran@peoplewithchemistry.com

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