Country Approval Specialist
Core
Manage and coordinate local regulatory submissions and site activation for clinical trials across multiple countries to align with global startup strategies.
Role type
Country Approval Specialist (Clinical Operations)
Builds
Local regulatory compliance and site activation for pharmaceutical/biotech clinical trials
Domain
Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local strategy development, stakeholder communication, project timeline management, document preparation, database management, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, grant budget negotiation, team leadership
Technologies
PPD tracking databases, regulatory submission systems
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, special applications), provide local regulatory strategy advice, contact investigators for submission activities, coordinate internal functional departments for site start-up alignment, lead local strategy for expedited site activation, develop country-specific patient information sheets and consent forms, maintain trial status information in tracking databases
Seniority
Mid-level, hands-on IC
