We are seeking a highly experienced, strategic, and influential Director of Regulatory Affairs to provide leadership for the development and execution of global regulatory strategies across a diverse portfolio of innovative development and marketed products.
This senior leadership role offers an exceptional opportunity to shape regulatory direction, influence development decisions, and drive successful product registrations in major global markets, with a strong emphasis on Europe.
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.
The successful candidate will lead the development and implementation of integrated global regulatory strategies, enabling efficient product development, accelerated approvals, lifecycle optimization, and sustainable compliance.
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.
The role will also contribute to organizational capability building, regulatory policy interpretation, health authority intelligence, and continuous improvement initiatives to enhance regulatory effectiveness and business performance.
Your area of responsibility:Contributes to the development, maintenance, and implementation of global regulatory strategies for assigned products, projects, submissions, or lifecycle activities under the direction of senior regulatory leadershipSupports strategic and operational regulatory planning across development, registration, and post-authorisation phases, including identification of regulatory risks, options, assumptions, and mitigation approachesSupports preparation, critical review, coordination, and submission o.