Experience supporting clinical development, marketing authorisation applications, lifecycle management, and post-authorisation regulatory activities - The Director will serve as a key regulatory leader and strategic partner to senior management, guiding cross-functional teams through complex regulatory challenges while ensuring regulatory excellence throughout the product lifecycle. Working closely with Development, Clinical, CMC, Safety, Market Access, Commercial, and Global Regulatory colleagues, the Director will provide strategic leadership for major development milestones, portfolio prioritization, market expansion initiatives, and regulatory risk management. * Supporting preparation, critical review, coordination, and submission of regulatory documents, including clinical trial applications, marketing authorisation applications, amendments, ...
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