Ctry Approval Spec
Core
Supports study startup by managing and coordinating local regulatory submissions (MoH, EC, special national applications) to enable clinical trial activation.
Role type
Country Approval Specialist (Clinical Operations)
Builds
Enables site activation for clinical trials across commercial and government contracts
Domain
Clinical research services / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, timeline alignment, database entry, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, feasibility coordination, budget negotiation support
Technologies
Company tracking databases, standard office equipment
Responsibilities
Prepares and coordinates local regulatory submissions; provides local regulatory strategy advice; coordinates site startup activities; maintains trial status information in tracking databases; ensures alignment of submission processes with critical paths; develops country-specific patient information documents; supports feasibility activities.
Seniority
Mid-level, hands-on IC
