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. * Serve as regulatory partner to Quality and Technical Development, ensuring alignment while maintaining a risk-based regulatory perspective. * Drive regulatory strategy for process changes, control strategies, specification setting, and comparability assessments. * Ensure high-quality, strategically coherent CMC regulatory documentation aligned with overall development plans and compliant with applicable regulatory regulations and guidelines.
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