Requirements & Experience:

• Support preparation of PSUR/PBRER and DSUR sections
• Compile data inputs from case processing and signal teams
• Ensure timelines and readiness for submissions
• Manage literature review outputs for aggregate reports
• Maintain reporting trackers and version control
• Coordinate review cycles and comment reconciliation
• Ensure references and appendices are complete
• Support responses to regulatory queries
• Ensure compliance with templates/SOPs
• Archive final reports and maintain audit trails