Executive Director, Regulatory Affairs Strategy - Cell Therapy

Role: Executive Director, Regulatory Affairs Strategy for Cell Therapy, responsible for shaping global regulatory strategies for complex, first-in-class cell therapy products from development through lifecycle management. Responsibilities include leading interactions with health authorities, defining target product labels, guiding submission strategies, and influencing policy to accelerate approval timelines and secure competitive labels. This senior leadership role involves managing multiple regulatory teams, providing strategic advice within global product teams, and ensuring timely delivery of regulatory milestones. The position emphasizes external engagement, policy shaping, risk management, and fostering innovation in regulatory processes. It also requires collaboration with cross-functional partners across discovery, development, and commercialization to optimize pathways and access for unmet medical needs. Requirements include a Bachelor’s degree in a science-related field with at least ten years of experience, demonstrated success in cell therapy regulatory strategy, and extensive knowledge of global regulatory science and development processes for high-profile biologics, especially in oncology, autoimmune, rare diseases, or neurology. Prior experience in complex, high-stakes interactions with health authorities, influencing policy, and leading diverse regulatory teams is essential. Preferred qualifications include a Master’s, PhD, or MD, with additional experience in multiple modalities and indications. The role offers a hybrid work setup with some in-office requirements, based in US locations, and involves strategic influence at an enterprise level to enable rapid, global patient access to innovative cell therapies.