Country Approval Specialist
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, special national applications) for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and country-level study files for pharmaceutical and biotech clients
Domain
Clinical Trials / Regulatory Affairs / Pharmaceuticals
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, experience with start-up CRA collaboration, familiarity with regional/national regulatory guidelines
Technologies
PPD tracking databases, internal SOPs, client SOPs
Responsibilities
Prepare and coordinate local regulatory submissions under guidance; 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 are prepared per SOPs
