Compliance

• Provide business support to Global Regulatory Affairs (GRA)
• Serve as key member of the Project Management Team to align Product and Regulatory strategy and operationalize plans with PMT and GRT
• Provide cross-functional leadership to submission teams in developing and executing submission plans for global filings
• Create and own regulatory project plans and develop project and portfolio level reports using various systems to support decision making
• Provide project management support for the regulatory end-to-end process from late development through launch
• Represent Regulatory Program Management at the GRT and PMT
• Translate regulatory strategy into realistic and executable regulatory deliverables using the Regulatory Strategy Document and Risk Registry
• Support early risk identification and development of mitigation strategies
• Collaborate with Regulatory Leader, Regulatory Liaisons and Professionals for regional Health Authority interactions and submissions (NA/EMEA/APJLA)
• Initiate discussions, establish Global filing plans, verify submission groups, and maintain plans in team SharePoint
• Ensure execution of plans through global and regional discussion, assess requirements and risks, monitor progress and critical path, and plan submission roll out
• Coordinate with Submission Operations for timing of pre-submission activities
• Act as single point of contact for Regulatory Program Management activities and proactively manage cross-functional project deliverables
• Monitor regulatory driven key milestones, decision points and critical path activities
• Create project related reports to support decision making at PMT, GRT and CDT levels and support regulatory portfolio oversight
• Assist GRTs in determining resource requirements using scheduling and resource management tools
• Coordinate creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs)
• Own Regulatory tasks in Planisware V6 and MSP S16 program schedules; create visuals using OnePager, OfficeTimeline, or Swimlane
• Proactively manage the regulatory development plan (scope, time, cost)

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