Country Approval Specialist-FSP-Belgium/ Netherlands
Core
Manage and coordinate local regulatory submissions for clinical trials in Belgium and the Netherlands to ensure alignment with global strategy and achieve target cycle times.
Role type
Senior regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and study files for pharmaceutical and biotech clients
Domain
Clinical research / Regulatory affairs / Life sciences
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, negotiation, medical terminology knowledge
Preferred skills
Knowledge of Belgian and Dutch regulatory guidelines, experience with gene therapy or viral safety dossiers
Technologies
PPD tracking databases, internal SOP systems
Responsibilities
Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national applications); Provide local regulatory strategy advice; Coordinate site start-up activities and feasibility; Maintain trial status information in tracking databases; Ensure alignment of submission processes with critical paths; Develop country-specific patient information sheets and consent forms.
Seniority
Mid-level, hands-on IC