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 Trials / Regulatory Affairs / Life Sciences
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, document preparation, feasibility coordination, budget negotiation support, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, medical terminology, knowledge of regional/national regulatory guidelines and EC regulations
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 country study files are prepared per SOPs; support feasibility and budget activities
Seniority
Mid-level, hands-on IC
