Country Approval Assoc
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 Associate (Clinical Trials Regulatory)
Builds
Regulatory submission packages and site activation alignment for clinical trials
Domain
Clinical research / Pharmaceutical regulatory affairs
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database maintenance, SOP compliance, feasibility coordination, budget negotiation support, patient information document development
Preferred skills
Knowledge of medical/therapeutic areas, familiarity with regional/national regulatory guidelines, experience with gene therapy or viral safety dossiers
Technologies
PPD tracking databases, clinical trial management software
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, import licenses), provide local regulatory strategy advice, coordinate site start-up activities with internal departments, maintain trial status information in tracking databases, ensure country study files comply with SOPs, support feasibility activities, assist with grant budget negotiations, develop Patient Information Sheets/Informed Consent forms
Seniority
Mid-level, hands-on IC