Country Approval 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 coordination for clinical trial site activations
Domain
Clinical research / Pharmaceutical regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission preparation, local regulatory strategy advice, project coordination, site start-up alignment, trial status tracking, SOP compliance
Preferred skills
Contact with investigators, grant budget negotiation, feasibility coordination, patient information document development
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 compliance with PPD and Client SOPs
Seniority
Mid-level, hands-on IC
