FSP Country Approval Specialist
Core
Prepare, review, and coordinate local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers) for clinical trials in alignment with global submission strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Local regulatory submissions and site start-up activities for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory submission preparation, local regulatory strategy advice, project coordination, regulatory compliance review, document development (Patient Information Sheets/Informed Consent forms), database management, SOP adherence
Preferred skills
Medical/therapeutic area knowledge, medical terminology, negotiation skills
Technologies
Study specific tracking databases, office software
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 local study files comply with SOPs
Seniority
Mid-level, 2+ years experience
