You will work in Tübingen, Munich or remote (Germany) and act as the key regulatory interface for CMC topics, working closely with Quality, Global Drug Supply and external manufacturing partners to ensure robust, pragmatic, and compliant CMC strategies. 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). * Translate manufacturing, analytical, and process development changes into clear regulatory impact assessments and submission strategies. * Drive regulatory strategy for process changes, control strategies, specification setting, and comparability assessments. * Demonstrated experience assessing regulatory impact of manufacturing changes and comparability strategies.
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