Position Summary: The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function. Essential functions of the job include but are not limited to: - Provides regulatory guidance throughout the clinical development life cycle - Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.
Also provides strategic regulatory input as required. - Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards - Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers - Works within a project team, and where necessary, leads project for the region or globally - Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. - Assist in development of Regulatory Affairs Specialists and other operational area staff, as required - P rovide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information - Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
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