Country Approval Specialist
Core
Manage and coordinate local regulatory submissions for clinical trials to ensure alignment with global strategy and support site activation.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and local study files for clinical trials
Domain
Clinical Research / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, site start-up alignment, trial status tracking, SOP compliance, document preparation (PIS/ICF), budget negotiation support, feasibility coordination
Preferred skills
Knowledge of gene therapy/viral safety dossiers, import license processes, interaction with investigators, grant budget management
Technologies
PPD tracking databases, client SOPs
Responsibilities
Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national applications); Provide local regulatory strategy advice to internal clients; Coordinate project-specific SIA services; Act as key contact for Ethical or Regulatory submissions; Align site start-up activities with submission timelines; Maintain trial status information in tracking databases; Ensure local study files and filing processes comply with SOPs
Seniority
Mid-level, hands-on IC
