Principal Country Approval Specialist (PCAS)
Core
Manages the preparation, review, and coordination of local regulatory submissions (MoH, EC, gene therapy approvals, import licenses) in alignment with global submission strategy to ensure timely site activations for clinical trials.
Role type
Senior IC regulatory operations specialist (clinical trials)
Builds
Regulatory compliance review packages, country study files, and submission documentation for clinical research projects.
Domain
Life sciences / Clinical research / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, local submission coordination, stakeholder management with authorities, contract scope identification, feasibility coordination, database maintenance, SOP compliance, mentorship, negotiation, project timeline alignment
Preferred skills
Knowledge of regional/national regulatory guidelines, medical/therapeutic area terminology, grant budget negotiation
Technologies
PPD regulatory intelligence systems, database management tools, internal/external software platforms
Responsibilities
Prepare and coordinate local regulatory submissions; provide local regulatory strategy advice to internal clients; serve as primary contact for investigators and regulatory authorities; ensure alignment of submission processes with critical path for site activation; maintain country master document templates; mentor team members; support feasibility activities; ensure accurate trial status information in databases.
Seniority
Senior, hands-on IC with mentorship responsibilities
