FSP Country Approval Specialist
Core
Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national applications) for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and country-specific study files for pharmaceutical and biotech clients.
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission preparation, local regulatory strategy advice, project coordination, compliance review package preparation, document development (Patient Information Sheets, Informed Consent forms), database entry for trial status, SOP adherence.
Preferred skills
Knowledge of gene therapy approvals, viral safety dossiers, import licenses, grant budget negotiations, feasibility activities.
Technologies
Study-specific tracking databases, office software.
Responsibilities
Coordinate with internal functional departments to align site start-up activities with submission timelines, maintain local country study files per SOPs, enter and maintain trial status information in tracking databases, develop country-specific patient information documents.
Seniority
Mid-level, hands-on IC
