Regulatory Affairs Study Start-up (RASSU) Coordinator

About the role

The RASSU Coordinator provides essential administrative and regulatory support to the Regulatory Affairs Study Start‑up (RASSU) department, ensuring that all documentation required for clinical trial submissions is accurately prepared, tracked, and maintained.

Key responsibilities

• Assist with collection, verification, and quality checks of regulatory documents from local study teams and sites.
• Prepare and manage expiration and reconciliation reports, as well as resourcing trackers.
• Support the preparation of study submission packages (initial submissions, amendments) for ethics and regulatory bodies.
• Coordinate shipments of regulatory documents, manage translation needs, and handle SUSAR submission packages.
• Maintain the RASSU SharePoint site, apply naming conventions, and upload documents to eTMF or paper TMF systems.
• Provide backup support for regulatory affairs activities and attend weekly team meetings.
• Assist in Business Intelligence report tracking and the development of project‑specific work instructions.

Required profile

• Bachelor’s degree in an allied health field (nursing, pharmacy, health or natural science).
• 0–1 year of research‑related or regulatory experience.
• Basic knowledge of medical and pharmaceutical terminology.
• Understanding of drug development and clinical trial processes.
• Proficiency with Microsoft tools for editing and finalizing legal regulatory documents.

Required skills

• Microsoft Office (Word, Excel, PowerPoint).
• SharePoint for document management.
• Business Intelligence (BI) reporting tools.