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Job

VP, Head of Regulatory Affairs

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Ryan Shaffer

  • Contact email:

    r.shaffer@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2019-11-10

  • Startdate:

    ASAP

A well funded pre-IPO Biotech startup in the San Fransisco Bay area is looking for a Head of Regulatory Affairs to establish the Regulatory Vision and provide a strategic pathway. You will report directly to C-suite, and will be the main FDA liason. This is an opportunity to make a huge impact, and drive forward an exciting Biotech in its initial stages. Assets are already in Play, with a BLA to be submitted by end of year.

 

Responsibilities:

  • Serve as the point of contact with major Health Authorities including FDA.
  • Represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
  • Provide strategic regulatory advice and speak with key stakeholders
  • Help with compound registration and follow-up closely on approvals of product registration and variations.
  • Build the Regulatory function, and advise C-suite on Regulatory pathways.

Qualifications:

  • Minimum of 12+ years regulatory experience
  • MBA + PhD/PhS/MD Strongly Preferred
  • BLA Submission experience required
  • Orphan Drug Designation experience a plus
  • Existing relationships with the FDA and other Health Reviewers preferred
  • Must be on-site near San Fransisco, comrehensive relocation package will be offfered

 

If you are interested in more information, please reach out to Ryan at 347-305-6781 or r.shaffer@hamlynwilliams.com