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  • Overview
  • Leadership
    • The Founders
    • Board of Directors
    • Scientific Advisory Board
  • News
  • Join Us
Oct 05

Associate Director / Director – Regulatory CMC

Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Associate Director / Director to join its growing team. The full-time role will be a key CMC leadership member, focused on preparing and implementing Garuda’s Regulatory strategy. Working closely within the R&D and CMC Departments, the ideal candidate will be responsible for helping bring much-needed therapies to patients. The position will be located in Natick, MA, or Cambridge, MA.

Key Responsibilities Include:

  • Providing leadership and strategic direction to support Garuda’s overall Regulatory plan
  • Supporting the R&D and CMC teams to enable successful INDs, CTAs, and Health Authority interactions
  • Ensuring that all CMC-related documentation is clear, concise, and meets necessary requirements
  • Reviewing clinical and nonclinical documents to ensure messaging is consistent with program strategy

Required Qualifications:

  • PhD with 3+ years of related experience, MS with 7+ years of related experience, or BS with 10+ years of related experience
  • Direct experience in Regulatory CMC, demonstrated by a record of successful INDs/CTAs
  • Working knowledge of FDA, EMA, and ICH guidelines
  • Attention to detail and careful record-keeping
  • Excellent organizational skills and ability to manage multiple projects
  • Excellent oral and written communication skills
  • Flexible team player excited to collaborate with internal and external partners

Preferred Qualifications:

  • Experience with cell and gene therapies; experience with iPSC-derived cell products is highly preferred

Please contact careers@garudatx.com to share your resume and learn more.

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Contact Info

22 Strathmore Road
Natick, MA 01760 USA
E-Mail: careers@garudatx.com

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