Directory, Regulatory

We are seeking an experienced and highly motivated professional to join our team as an Associate Director, Regulatory. This role will serve as the Regulatory Lead for our pivotal program leading to BLA. In this role, you will be responsible for developing and executing regulatory strategies to support the development and commercialization of our cell therapy products. You will work closely with cross-functional teams, regulatory agencies, and external partners to ensure compliance with regulatory requirements and successful product registration. Responsibilities include managing all regulatory aspects through pivotal clinical studies and BLA/MAA approval, preparing regulatory documents, ensuring compliance, representing the company in interactions with regulatory agencies, and building positive relationships to facilitate approvals.