Ctry Approval Assoc
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-level regulatory submission associate
Builds
Regulatory compliance review packages and country-specific study files for clinical trial site activation
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, feasibility coordination
Preferred skills
Contact with investigators, budget negotiation support, patient information document development
Technologies
PPD tracking databases
Responsibilities
Prepare and review local regulatory submissions; provide local regulatory strategy advice; coordinate project-specific SIA services; maintain trial status information on tracking databases; ensure alignment of submission processes with site activation timelines; develop country-specific patient information documents; support feasibility activities.
Seniority
Individual contributor, execution level
