Country Approval Specialist
Core
Manage and coordinate local regulatory submissions (MoH, EC, special national applications) for clinical trials in alignment with global strategy.
Role type
Regulatory submission coordinator (clinical trials)
Builds
Regulatory compliance packages for site activation across 100+ countries
Domain
Clinical research / Pharmaceutical regulatory affairs
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database entry, feasibility coordination, budget negotiation support, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, medical terminology, knowledge of regional/national regulatory guidelines and EC regulations
Technologies
PPD tracking databases, internal SOPs
Responsibilities
Prepare, review, and coordinate local regulatory submissions; provide local regulatory strategy advice; coordinate site start-up activities; maintain trial status information in tracking databases; ensure alignment of submission processes with critical paths; develop country-specific patient information sheets and consent forms.
Seniority
Mid-level, execution-focused