Associate Director, Regulatory Affairs

Regulatory Strategist – Advanced Therapeutics (Associate Director) 

Our biotech client is pioneering next-generation regenerative medicine and seeking a Regulatory Expert to lead efforts in defining and executing regulatory strategy for a cutting-edge tissue engineering program. This is an opportunity to join a mission-driven, collaborative, and scientifically rigorous team dedicated to transforming the future of transplantation and therapeutic development.

Key Responsibilities:

  • Lead regulatory strategy for complex biologics, including preparation and execution of IND submissions

  • Manage timelines, documentation, and communication across cross-functional teams to ensure alignment and compliance

  • Collaborate closely with scientific, clinical, and quality teams to support regulatory submissions in eCTD format via the ESG

  • Guide long-term regulatory planning, contributing to the broader clinical and commercial strategy
     

Minimum Qualifications:

  • Bachelor’s Degree, minimum (higher education preferred!) 

  • 8+ years of industry regulatory affairs experience in biologics or pharmaceuticals 

  • 8+ years of project or team leadership experience

  • Direct experience writing and submitting INDs via the ESG in eCTD format

  • Demonstrated success in leading regulatory submissions and influencing strategy through data-driven insights

  • Excellent cross-functional communication and collaboration skills in hybrid or remote settings

  • Experience mentoring and guiding team members at various levels

  • In-depth knowledge of FDA regulations, particularly 21 CFR 1271 and 21 CFR 312.
     

This is a rare chance to shape regulatory direction at the forefront of biotech innovation. If you’re motivated by science, impact, and working with exceptional people, we encourage you to apply.