Country Approval Specialist
Core
Manage and coordinate local regulatory submissions (MoH, EC, gene therapy, viral safety) for clinical trials in alignment with global strategy.
Role type
Senior IC regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and local study files for pharmaceutical and biotech clients
Domain
Life sciences / Clinical trials / Regulatory affairs
Required skills
Regulatory guideline knowledge, submission coordination, project management, database management, document preparation, negotiation, medical terminology
Preferred skills
Knowledge of regional/national regulatory guidelines, experience with gene therapy or viral safety dossiers
Technologies
PPD tracking databases, office software
Responsibilities
Prepare and review local regulatory submissions; provide local regulatory strategy advice; coordinate site start-up activities; maintain trial status information in databases; ensure alignment of submission processes with critical paths; develop patient information sheets and consent forms.
Seniority
Mid-level, hands-on IC
