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 independently lead EU regulatory activities for assigned clinical programs and act as a of regulatory strategy and execution. * Lead the preparation and coordination of Scientific Advice and other Health Authority interactions, including briefing documents, responses to questions, and meeting follow-up. This includes preparation, review and maintaining documentation of clinical trial applications. * 8+ years of Regulatory Affairs experience in biopharmaceuticals and/or ATMPs. * High degree of personal responsibility, enthusiasm, team spirit, and reliability. * Experience aligning cross-functional teams and driving resolution of regulatory challenges. We are the global leader in precision targeting of PRAME.
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