Regulatory Program Management - Sponsor Dedicated

The RPM will provide business support to GRA. Key member of the Project Management Team ensuring the Product strategy aligns with the Regulatory strategy and works in concert with the PMT and GRT to operationalize the plans. Provides cross‑functional leadership to the submission teams in developing and executing the submission plans for Global filings. Creates and owns the regulatory project plans and develops project and portfolio level reports utilizing various systems to support key decision making.

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Deliverables

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• Provide project management support for the regulatory end‑to‑end process from entry into late development through launch.
  
• Represent “Regulatory Program Management” at the GRT.
  
• Translate regulatory strategy into realistic and executable regulatory deliverables with clear assumpti...