Regulatory and Start Up Specialist - Netherlands

As an RSU Specialist you will drive site activation in the Netherlands, ensuring regulatory compliance and smooth collaboration with sites, SAMs, and project teams. You will serve as the regulatory and activation expert, coordinating country-specific activities and delivering timely documentation. You help manage relationships with sponsors and stakeholders to accelerate study start-up while upholding local regulations and SOPs. This role offers home-based work within Belgium and Belgium-related flexibility within a global healthcare setting.

• home-based flexibility within Belgium
• global career development
• exposure to diverse therapeutic areas
• collaborative and inclusive culture
• growth and continuous learning
• impactful clinical studies

• Serve as primary contact for investigative sites, Site Activation Managers, Project Managers, and internal stakeholders
• Coordinate and execute country-specific site activation and regulatory activities
• Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance
• Track and manage submission, approval, and execution of essential documents (Regulatory submissions, Ethics Committee submissions, Informed Consent Forms, Investigator Pack release, CTAs)
• Support contract negotiation activities and timelines
• Maintain accurate records within internal systems and tracking tools
• Monitor project milestones and identify risks with mitigation plans
• Provide local regulatory expertise to project teams and Site Activation Managers
• Perform quality reviews of site documentation
• Review site performance metrics and contribute to process improvement
• Collaborate with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery

• Bachelor's degree in Life Sciences or related field
• Approx. 3.5–5 years' experience in clinical research
• Strong experience in site activation, regulatory submissions, CTAs and contract negotiations, and start-up activities
• Solid understanding of Belgian and international clinical trial regulations
• Fluency in Dutch and strong English communication skills
• Excellent planning, organization, and problem-solving abilities
• Ability to manage multiple priorities in a fast-paced environment
• Strong stakeholder management and communication skills

• stakeholder management
• communication
• planning
• Site Activation
• Regulatory submissions
• Clinical Trial Agreements (CTAs)