The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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The Regulatory Operations Manager - Therapeutics will be responsible for submissions management activities (planning, publishing and archiving) of Merz products, as well as the implementation/update of Regulatory systems. This role will provide operational expertise and project leadership for ongoing and future technology projects, systems, business process changes and user training. For submissions management, the Reg Ops Manager will have overall accountability in managing the logistics, planning, preparation, quality assurance, delivery and archival of regulatory submissions and allied documentation, including correspondence (drugs and medical devices) in compliance with Regulatory agency requirements, company standards, and timelines. DESCRIPTION
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