Associate Director Regulatory Affairs – CMC Lead*
Associate Director Regulatory Affairs – CMC Lead*
Immatics Biotechnologies GmbH
Tübingen, München, Home-Office
Teilweise Home-Office
In this role, you will provide strategic CMC regulatory leadership for innovative oncology biopharmaceutical and ATMP programs across clinical development phases. You will independently lead EU CMC regulatory strategy and execution for assigned programs across early and late-stage clinical development. * Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I–III). * Lead preparation and coordination of CMC/ GMP documentation for submission of initial clinical trial applications as well as Substantial Modifications. * Strong experience preparing CMC-related information/ documents for clinical trial applications and supporting Health Authority interactions.
In this role, you will provide strategic CMC regulatory leadership for innovative oncology biopharmaceutical and ATMP programs across clinical development phases. You will independently lead EU CMC regulatory strategy and execution for assigned programs across early and late-stage clinical development. * Own EU CMC regulatory strategy for assigned clinical-stage programs (phase I–III). * Lead preparation and coordination of CMC/ GMP documentation for submission of initial clinical trial applications as well as Substantial Modifications. * Strong experience preparing CMC-related information/ documents for clinical trial applications and supporting Health Authority interactions.