FSP Country Approval Specialist
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers) for clinical trials in alignment with global strategy.
Role type
Specialist regulatory submission coordinator
Builds
Clinical trial site activation and regulatory compliance packages
Domain
Clinical research / Pharmaceutical regulatory affairs
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, medical terminology knowledge
Preferred skills
Gene therapy/viral safety dossier experience, grant budget negotiation, feasibility activity coordination
Technologies
PPD tracking databases, client SOPs
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
Seniority
Mid-level specialist (2+ years experience)
