Associate Director, Regulatory Affairs - Hireminds : Job Details

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.