Country Approval Specialist / Sr Country Approval Specialist - FSP - Belgium
Core
Manage and coordinate local regulatory submissions (MoH, EC, special national applications) for clinical trials in alignment with global strategy.
Role type
Senior IC country regulatory specialist
Builds
Regulatory submission packages and site activation alignment for clinical trials
Domain
Clinical trials / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database maintenance, SOP compliance, feasibility coordination, budget negotiation support, patient information document development
Preferred skills
Knowledge of gene therapy approvals, viral safety dossiers, import licenses, start-up CRA collaboration
Technologies
PPD tracking databases, client SOPs
Responsibilities
Prepare and review local regulatory submissions, provide local regulatory strategy advice, coordinate site start-up activities, maintain trial status information, ensure alignment of submission processes with critical paths, develop country-specific patient information documents, support feasibility activities
Seniority
Senior, hands-on IC
