FSP Country Approval Specialist
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers, import licenses) for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and local study files for clinical trials
Domain
Clinical Trials / Regulatory Affairs
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, document preparation, negotiation, knowledge of regional/national regulatory guidelines
Preferred skills
Medical/therapeutic area knowledge, medical terminology, feasibility coordination, grant budget negotiation
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 alignment of submission processes with critical paths; develop Patient Information Sheets and Informed Consent forms.
Seniority
Mid-level, execution-focused IC