Senior Country Approval Specialist
Core
Manage preparation, review, and coordination of local regulatory submissions (MoH, EC, gene therapy, viral safety) for clinical trials in alignment with global strategy.
Role type
Senior Country Approval Specialist (Clinical Regulatory)
Builds
Regulatory compliance review packages, submission dossiers, and country-specific patient information documents.
Domain
Life Sciences / Clinical Trials / 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 development, stakeholder management with authorities, contract scope identification, study file oversight, SOP compliance, mentorship
Preferred skills
Medical/therapeutic area knowledge, grant budget negotiation, feasibility activity coordination
Technologies
Clinical trial databases, regulatory submission software
Responsibilities
Prepare and coordinate local regulatory submissions; provide local regulatory strategy advice; serve as primary contact for investigators and authorities; oversee country study files; maintain trial status information; mentor team members; resolve regulatory process anomalies.
Seniority
Senior, hands-on IC with mentorship duties
