Ctry Approval Spec
Core
Supports study startup by managing and coordinating local regulatory submissions (MoH, EC, special national applications) in alignment with global strategy for clinical trials.
Role type
Country Approval Specialist (Clinical Operations)
Builds
End-to-end clinical trial support services for commercial and government clients
Domain
Clinical research services / Life sciences
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, database entry, feasibility coordination, budget negotiation support, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, medical terminology, regional/national regulatory guidelines knowledge
Technologies
Company tracking databases, standard office equipment
Responsibilities
Prepare, review, and coordinate local regulatory submissions; provide local regulatory strategy advice; coordinate site startup activities; maintain trial status information in tracking databases; ensure alignment of submission processes with critical paths; develop patient information sheets or informed consent forms; assist with grant budget negotiations; support feasibility activities.
Seniority
Mid-level, hands-on IC
