Regulatory Affairs Director

5 hours ago


Reston, Virginia, United States Trebla Talent Full time

Role:

Biotech Regulatory Affairs Director

Location: Bay Area - Hybrid

Company Overview:

Trebla Talent is proud to partner with a leading cell therapy CART biotech developing innovative treatments for chronic autoimmune disorders.

Job Summary:

We are seeking a seasoned Regulatory Affairs Director to lead Allogeneic trials, leveraging their expertise in strategic discussions and decisions. This role will be globally facing as the company expands its targets.

Key Responsibilities:

  • Lead Regulatory Affairs efforts for Allogeneic trials
  • Develop and implement regulatory strategies
  • Collaborate with cross-functional teams
  • Ensure compliance with global regulations

Requirements:

  • Bachelor's Degree in Life Sciences
  • 10+ years of Regulatory Affairs experience in pharma or biotech
  • Cell Therapy or Gene Therapy experience required
  • IND/CTA, BLA/MAA submissions experience
  • Global regulations knowledge

About the Company:

This company is a pioneer in cell therapy, with a strong track record of innovation and success. If you're passionate about regulatory affairs and want to be part of a dynamic team, we encourage you to apply.



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