Country Approval Specialist/ Sr. Country Approval Specialist - FSP client dedicated
Core
Manage and coordinate local regulatory submissions (MoH, EC, special national applications) for clinical trials to ensure alignment with global strategy and timely site activation.
Role type
Senior IC country regulatory operations specialist
Builds
Regulatory compliance review packages, country-specific study files, and submission dossiers for pharmaceutical and biotech clients
Domain
Clinical trials / Regulatory affairs / Life sciences
Deliverable
client delivery
Required skills
Local regulatory submission preparation and coordination, regulatory strategy advice, project coordination, database management, study file maintenance, negotiation, medical terminology knowledge
Preferred skills
Experience with gene therapy or viral safety dossiers, feasibility activity coordination, grant budget negotiation
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, ensure alignment of submission processes with critical paths, develop patient information sheets and informed consent forms
Seniority
Mid-level, hands-on IC
