FSP Country Approval Specialist
Core
Manage and coordinate local regulatory submissions (MoH, EC, gene therapy, viral safety) for clinical trials in alignment with global strategy.
Role type
Senior regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and site activation alignment for pharmaceutical/biotech clinical trials
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
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 coordination
Technologies
PPD tracking databases, client SOPs
Responsibilities
Prepare and review 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/Informed Consent forms.
Seniority
Mid-level, hands-on IC
