Reg Affairs Officer 2

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)

Time Zone: Preferred EU time zone as requested by client.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com