Ctry Approval Spec
Core
Supports study startup by managing and coordinating local regulatory submissions (MoH, EC, special national applications) in alignment with global strategy.
Role type
Specialist, clinical trial regulatory operations
Builds
Clinical trial startup services for commercial and government contracts
Domain
Clinical research services / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, negotiation, medical terminology knowledge
Preferred skills
Knowledge of regional/national regulatory guidelines, EC regulations
Technologies
Company tracking databases, standard office equipment
Responsibilities
Prepare and coordinate local regulatory submissions; provide local regulatory strategy advice; coordinate site startup activities; maintain trial status information in databases; ensure alignment of submission processes with critical paths; support feasibility activities; maintain country study files.
Seniority
Mid-level, individual contributor
