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Key Responsibilities and Accountabilities:
Including, but not limited to the following

• Participates in the creation of submission content plans in Regulatory Document Management System or health authority submission portals (e.g., IRIS, CTIS) and monitors progress of the submission
• Authors administrative sections (including cover letters and submission forms) and manages preparation of other documents for routine submissions
  • Examples: investigator submissions, annual reports, PSURs, DSURs, Orphan Drug annual reports, and IND Safety Reports
  • Coordinates activities with other functional groups
• Coordinates submission documents through review cycles and provides guidance for uploading and managing documents in the regulatory submission document management system
  • Supports affiliates as needed
• Coordinates team meetings for major and routine submissions aligned with the GRL and EU/US Regulatory Strategy Leads
• Manages overall completeness of scheduled submissions and coordinates with the Publishing Lead on status of documents and submission timelines
  • Reviews published output
• Participates in operational excellence initiatives (improvement projects)