인재풀 - Country Approval Specialist (SSU)
Core
Manages preparation, review, and coordination of local regulatory submissions for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Operations)
Builds
Regulatory submission packages and country-specific study activation plans
Domain
Clinical research services / Regulatory affairs
Deliverable
client delivery
Required skills
Local regulatory guidelines knowledge, submission strategy development, stakeholder coordination, documentation management, contract review, feasibility support
Preferred skills
Medical/therapeutic area knowledge, mentorship, negotiation
Technologies
Clinical trial databases, regulatory submission systems
Responsibilities
Prepare and review local regulatory submissions (EC, gene therapy, viral safety), develop local submission strategies, serve as primary contact for investigators and regulatory authorities, coordinate site start-up activities, maintain trial status databases, oversee country study files
Seniority
Mid-level, hands-on IC
