Director, Regulatory Affairs

Role: Director of Regulatory Affairs responsible for developing and executing global regulatory strategies for cell therapy assets, including CAR-T, TCR-T, and NK cell therapies, with a focus on advancing programs through IND/CTA/BLA filings and regulatory interactions. Responsibilities: independently lead regulatory strategy formulation, oversee submissions and maintenance of regulatory dossiers, coordinate with health authorities (FDA, ex-US agencies), serve as the regulatory team representative in cross-functional development teams, and mentor junior staff. Qualifications: PharmD or PhD in science/healthcare, 7+ years in regulatory affairs with expertise in biologics, cell therapies, and global filings; experience in IND/CTA/BLA processes, with a strong understanding of regulatory landscape in oncology and immunology. Preferred: knowledge of companion diagnostics, drug development in multiple myeloma, and experience with CDx development. High-Value: biologics and cell therapy modalities, late-stage clinical development (IND/CTA/BLA), global regulatory strategy, and cross-functional collaboration. Work Setup: based in Somerset, NJ, with regular engagement in international regulatory activities.