Associate Director Regulatory Affairs – Clinical Lead*

Job description

OVERVIEW: We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development. You will work in Tübingen, Munich or remote (Germany) in a highly collaborative international environment and act as key regulatory leader within cross-functional teams, ensuring clear, pragmatic, compliant and strategically aligned regulatory positioning. YOUR MISSION: You will independently lead EU regulatory activities for assigned clinical programs and act as a key driver of regulatory strategy and execution. Your main responsibilities as RA Clinical Lead will include but are not limited to the following tasks: Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization. Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while ensuring compliance with regulatory requirements Lead the preparation and coordination of Scientific Advice and...