FSP Bench Country Approval Specialist

Overview

The Country Approval Specialist manages and coordinates local regulatory and ethics submissions for clinical studies in Peru, supporting site activation and study timelines.

What you'll do

• Prepare, review and coordinate local regulatory submissions under guidance.
• Provide local regulatory strategy advice to internal clients.
• Coordinate local project-specific site initiation activities.
• Coordinate submission-related activities with investigators and internal departments.
• Prepare regulatory compliance review packages with start-up CRAs when applicable.
• Maintain trial status information and country study files.
• Support feasibility activities and site budget or payment schedule negotiations.

What you'll need

• Bachelor's degree or equivalent relevant qualification.
• At least 2 years of comparable experience.
• Knowledge of applicable national regulatory guidelines and ethics committee regulations.
• Strong oral and written communication skills.
• Strong attention to documentation quality and detail.
• Basic medical terminology knowledge.
• Good English language and grammar skills.

Details

• Remote role in Peru.
• Standard Monday-Friday schedule.