FSP Country Approval Specialist (all level)
Core
Manage preparation, review, and coordination of local regulatory submissions and site contract/budget negotiations to ensure timely clinical trial start-up.
Role type
Senior Clinical Trial Start-up & Regulatory Specialist
Builds
Clinical trial sites and regulatory approvals for pharmaceutical/biotech clients
Domain
Clinical Research / Regulatory Affairs / Contract Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission strategy, site contract negotiation, budget negotiation, stakeholder coordination, risk management, compliance review, study file management, regulatory guideline knowledge
Preferred skills
Mentorship, feasibility coordination, grant budget negotiation, database maintenance
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Prepare and coordinate local regulatory submissions (HSA, EC, gene therapy, viral safety), lead site contract and budget negotiations, develop country-specific patient information documents, oversee country study files, liaise with regulatory authorities and internal functions, mentor team members
Seniority
Senior, hands-on IC with mentorship responsibilities
