FSP Country Approval Associate
Core
Prepare, review, and coordinate country submissions for clinical trials in alignment with global strategy, supporting site start-up activities and regulatory compliance.
Role type
Country Approval Associate (Clinical Trials)
Builds
Regulatory submission packages and country-specific study files for clinical trial sites
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Regulatory guidelines knowledge, submission coordination, site start-up alignment, document preparation, database management, budget negotiation, SOP compliance
Preferred skills
Medical/therapeutic area knowledge, English language proficiency, computer skills
Responsibilities
Prepare and review local EC and MoH submissions, coordinate with internal departments for site activation, maintain trial status in tracking databases, assist in developing patient information sheets and consent forms, negotiate grant budgets with sites, ensure compliance with PPD and Client SOPs
Seniority
Junior, 0-2 years experience
