Compliance

• Provide business support to Global Regulatory Affairs (GRA)
• Serve as key member of the Project Management Team ensuring product strategy aligns with regulatory strategy
• Provide cross-functional leadership to submission teams to develop and execute global submission plans
• Create and own regulatory project plans and develop project and portfolio level reports
• Provide project management support from late development through launch and represent Regulatory Program Management at GRT and PMT
• Translate regulatory strategy into executable regulatory deliverables and work out regulatory scenarios to support decision making
• Support early risk identification and development of mitigation strategies
• Collaborate with Regulatory Leader (GRL), Regulatory Liaisons and Professionals on regional health authority interactions and submissions
• Initiate discussion, establish Global filing plans, verify submission groups, and maintain plans in team SharePoint
• Ensure execution of plans through monitoring progress, assessing critical path, and planning submission roll out
• Coordinate timing of pre-submission activities with Submission Operations
• Act as single point of contact for Regulatory Program Management activities and proactively manage cross-functional deliverables
• Monitor regulatory-driven milestones, decision points and critical path activities; create reports for PMT, GRT and CDT
• Assist GRTs in determining resource requirements and coordinate creation and management of regulatory project budgets (OOPs & FTEs)
• Own regulatory tasks in Planisware V6 and MSP S16 schedules and Submission plan in MSP16; create visuals using OnePager, OfficeTimeline, or Swimlane
• Collaborate with CDT Program Management Leader and PMT Program Managers to ensure alignment of strategies and proactively manage scope, time, and cost of regulatory development plan

Strategy Manager, Regulatory Program

Business Control Manager – Technology Risk & Regulatory Engagement Lead

Business Control Manager – GT Risk & Regulatory Engagement Lead

Business Control Manager – Technology Risk & Regulatory Lead

Quality Specialist – Customer Compliance

Senior Director, Compliance & Ethics – PRISM, Multi-Specialty MSOs