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 Research / 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, clinical trial management software
Responsibilities
Prepare and review local regulatory submissions, coordinate site start-up activities, maintain trial status information, ensure alignment with critical path for site activation, develop country-specific patient information documents
Seniority
Mid-level, hands-on IC
