Country Approval Specialist
Core
Manage and coordinate local regulatory submissions (MoH, EC, special national applications) for clinical trials to ensure alignment with global strategy and support site activation.
Role type
Country Approval Specialist (Clinical Trial Regulatory)
Builds
Regulatory compliance review packages, country-specific study files, and submission dossiers for clinical trials.
Domain
Clinical Research / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, knowledge of regional/national regulatory guidelines, medical terminology knowledge
Preferred skills
Experience with gene therapy approvals, viral safety dossiers, import licenses, grant budget negotiations, feasibility activities
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 country study files are prepared per SOPs.
Seniority
Individual Contributor, execution level
