Regulatory and Start Up Specialist - Netherlands
Core
Manage site identification, regulatory submissions, ethics approvals, and site activation activities to accelerate clinical trial start-up.
Role type
Senior IC clinical trial start-up specialist
Builds
Clinical trial site activation and regulatory compliance for pharmaceutical sponsors
Domain
Life sciences / Clinical research
Required skills
Clinical trial regulatory affairs, site identification, feasibility assessment, contract negotiation, local/international regulatory requirements knowledge, GCP, document management
Preferred skills
Experience with therapeutic areas, cross-functional collaboration, process improvement
Technologies
Internal tracking systems, regulatory submission platforms
Responsibilities
Execute site identification and feasibility assessments; Prepare and review regulatory documentation; Track and manage submission and approval of essential documents; Review, negotiate, and manage site contracts; Monitor project milestones and identify risks; Provide local regulatory expertise to project teams.
Seniority
Mid-level, hands-on IC
