Country Approval Specialist - FSP
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers) for clinical trials in alignment with global strategy.
Role type
Specialist regulatory submission coordinator
Builds
Clinical trial site activation and regulatory compliance packages
Domain
Clinical trials / Oncology / Cell therapy
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database entry, feasibility coordination, budget negotiation support, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, medical terminology, knowledge of regional/national regulatory guidelines
Technologies
PPD tracking databases, client SOPs
Responsibilities
Prepare and coordinate local regulatory submissions, provide local regulatory strategy advice, coordinate site start-up activities, maintain trial status information, ensure alignment of submission processes with critical paths, develop patient information sheets, assist with grant budget negotiations, support feasibility activities
Seniority
Specialist, execution level