Regulatory Professional

Kort om jobbet

. We are looking for a Regulatory Affairs Professional to join RA CMC & Device in the area handling life-cycle management and late-stage development for the semaglutide pipeline. The role offers the opportunity to become a subject matter expert in our leading international organisation and to take the lead in setting the strategic direction for products of great importance to Novo Nordisk’s growth on a global level. Your new role The role will both involve working with late-stage development and life-cycle management submissions worldwide where you will be at the centre of project planning and execution, responsible for planning, coordinating, and reviewing regulatory documentation related to the drug, including preparing applicable sections of submission packages, responses to agency questions for global markets, and agency meeting packages. You will be accountable for: Planning, executing and driving strategic regulatory CMC activities and submissions Applying CMC regulatory intelligence to develop robust regulatory strategies Identifying and improving regulatory CMC practices, processes, and approaches related to regulatory CMC documentation and strategies. Your new department Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets1 …

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