Manager Regulatory Affairs - Submission Lead*

Job description

OVERVIEW: We are currently seeking a Manager Regulatory Affairs – Submission Lead * to strengthen our Regulatory Affairs department. You will work in Tübingen, Munich or remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US and will contribute to our mission of delivering novel PRAME immunotherapies to patients with cancer. This position is a fixed-term role of 18 months as it covers a maternity leave. YOUR MISSION: Your main responsibilities will include but are not limited to the following tasks: Serve as the EU Submission Lead for assigned clinical trials and act as primary contact for submission planning and execution. Lead the preparation and submission of initial applications and amendments via CTIS and oversee end‑of‑trial submissions. Coordinate all regulatory submission activities in collaboration with the Regulatory Affairs Project Lead, including coordination of external vendors and partners. Ensure compliance with regulatory requirements, provide regulatory oversight for site‑related documentation, and ensure timely delivery of complete and accurate Part II application packages. Drive submission readiness, including compilation, do...