Country Approva Specialist
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers, import licenses) for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and local study files for clinical trials
Domain
Clinical trials / Life Sciences / Regulatory Affairs
Required skills
Regulatory submission coordination, Local regulatory strategy advice, Project coordination, Ethical/Regulatory submission management, Site start-up alignment, Trial status tracking, SOP compliance, Medical terminology knowledge
Preferred skills
Gene therapy approval experience, Viral safety dossier experience, Grant budget negotiation, Feasibility activity coordination
Technologies
PPD tracking databases, Client SOPs
Responsibilities
Prepare and coordinate local regulatory submissions; Provide local regulatory strategy advice; Coordinate site start-up activities; Maintain trial status information in tracking databases; Ensure local study files are prepared per SOPs; Maintain knowledge of regulatory guidelines.