<p>Regulatory Strategist - Advanced Therapeutics (Associate Director)</p> <p>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.</p> <p>Key Responsibilities:</p> <ul> <li> <p>Lead regulatory strategy for complex biologics, including preparation and execution of IND submissions</p> </li><li> <p>Manage timelines, documentation, and communication across cross-functional teams to ensure alignment and compliance</p> </li><li> <p>Collaborate closely with scientific, clinical, and quality teams to support regulatory submissions in eCTD format via the ESG</p> </li><li> <p>Guide long-term regulatory planning, contributing to the broader clinical and commercial strategy</p> </li></ul> <p>Minimum Qualifications:</p> <ul> <li> <p>Bachelor's Degree, minimum (higher education preferred!)</p> </li><li> <p>8+ years of industry regulatory affairs experience in biologics or pharmaceuticals</p> </li><li> <p>8+ years of project or team leadership experience</p> </li><li> <p>Direct experience writing and submitting INDs via the ESG in eCTD format</p> </li><li> <p>Demonstrated success in leading regulatory submissions and influencing strategy through data-driven insights</p> </li><li> <p>Excellent cross-functional communication and collaboration skills in hybrid or remote settings</p> </li><li> <p>Experience mentoring and guiding team members at various levels</p> </li><li> <p>In-depth knowledge of FDA regulations, particularly 21 CFR 1271 and 21 CFR 312.</p> </li></ul> <p>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.</p> <p>*</p>