Supporting preparation, critical review, coordination, and submission of regulatory documents, including clinical trial applications, marketing authorisation applications, amendments, variations, supplements, responses to health authority questions, and lifecycle submissions * Providing regulatory input to cross-functional teams to support compliant development plans, clinical trial designs, submission documents, labelling considerations, and lifecycle activities - 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. * Experience supporting clinical development, marketing authorisation applications, lifecycle management, and post-authorisation regulatory activities
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