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:
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Lead regulatory strategy for complex biologics, including preparation and execution of IND submissions
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Manage timelines, documentation, and communication across cross-functional teams to ensure alignment and compliance
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Collaborate closely with scientific, clinical, and quality teams to support regulatory submissions in eCTD format via the ESG
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Guide long-term regulatory planning, contributing to the broader clinical and commercial strategy
Minimum Qualifications:
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Bachelor’s Degree, minimum (higher education preferred!)
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8+ years of industry regulatory affairs experience in biologics or pharmaceuticals
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8+ years of project or team leadership experience
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Direct experience writing and submitting INDs via the ESG in eCTD format
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Demonstrated success in leading regulatory submissions and influencing strategy through data-driven insights
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Excellent cross-functional communication and collaboration skills in hybrid or remote settings
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Experience mentoring and guiding team members at various levels
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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.