Regulatory and Start‑Up Specialist – Belgium

About the role

This position supports site activation and regulatory start‑up activities for clinical studies in Belgium. Working remotely, you will act as the single point of contact for investigative sites, the Site Activation Manager and the project team, ensuring compliance with local and international regulations.

Key responsibilities

• Coordinate site activation tasks, including preparation, distribution and tracking of regulatory documents.
• Maintain internal databases and tracking tools with accurate project‑specific information.
• Review site regulatory packages for completeness, accuracy and adherence to SOPs.
• Monitor site performance metrics and provide feedback to management.
• Support contract negotiations and local submissions in Dutch and French.
• Implement contingency plans and ensure quality control of site‑provided documents.

Required profile

• Fluency in Dutch and French, both written and spoken.
• Experience with regulatory submissions, site activation and contract negotiations in a clinical research environment.
• Strong attention to detail and ability to work independently under general supervision.
• Excellent organizational skills to manage multiple timelines and documentation streams.

Required skills

• Regulatory document preparation and review.
• Site activation processes.
• Contract negotiation.
• Use of internal tracking systems and databases.

What we offer

• Home‑based work arrangement.
• Opportunity to work with a global leader in clinical research services.
• Collaborative environment with cross‑functional project teams.