FSP Country Approval Specialist
Core
Prepares, reviews, and coordinates 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
Clinical research / Regulatory affairs / Pharmaceuticals
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, feasibility coordination, document development (PIS/ICF), budget negotiation support
Preferred skills
Knowledge of medical/therapeutic areas, familiarity with regional/national regulatory guidelines
Technologies
PPD tracking databases, office software
Responsibilities
Prepare and coordinate local regulatory submissions; provide local regulatory strategy advice; coordinate site start-up activities; maintain trial status information in databases; ensure study files comply with SOPs; support feasibility activities
Seniority
Mid-level, hands-on IC
