FSP 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
Regulatory submission specialist (clinical trials)
Builds
Regulatory compliance review packages and country-specific submission documents
Domain
Life sciences / Clinical trials / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory guidelines knowledge, submission coordination, project coordination, database management, SOP adherence, medical terminology
Preferred skills
Gene therapy/viral safety knowledge, negotiation, feasibility coordination
Technologies
PPD tracking databases
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.
Seniority
Mid-level, hands-on IC
