Country Approval Specialist - FSP
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
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and local study files for clinical trials
Domain
Clinical research / Pharmaceutical regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database entry, feasibility coordination, budget negotiation support, SOP compliance
Preferred skills
Knowledge of oncology/cell therapy, experience with gene therapy approvals, familiarity with PPD/PPD WPDs
Technologies
PPD tracking databases, regulatory submission software
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, special national applications), provide local regulatory strategy advice, coordinate site start-up activities, maintain trial status information in tracking databases, ensure alignment of submission processes with critical paths, develop Patient Information Sheets/Informed Consent forms, support grant budget negotiations, coordinate feasibility activities
Seniority
Mid-level, hands-on IC
