FSP Country Approval Associate
Core
Prepare, review, and coordinate country submissions for clinical trial site activations in alignment with global strategy.
Role type
Associate (0-2 years experience)
Builds
Regulatory compliance review packages and country-specific study files
Domain
Clinical trials / Regulatory affairs
Required skills
Regulatory guidelines knowledge, submission coordination, document preparation, database management, negotiation, medical terminology
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare and review local EC and MoH submissions; Coordinate with internal departments for site start-up alignment; Maintain trial status in tracking databases; Assist in developing Patient Information Sheets and Informed Consent forms; Negotiate grant budgets with sites.
Seniority
Junior, entry-level IC
