FSP Country Approval Specialist

Overview

The Country Approval Specialist prepares, reviews, and coordinates country-level regulatory and ethics submissions for clinical studies, supporting site activation and submission timelines.

What you'll do

• Prepare, review, and coordinate local regulatory submissions under guidance.
• Provide local regulatory strategy advice to internal clients.
• Coordinate submission-related activities with investigators and internal departments.
• Align site start-up activities and submission processes with study timelines.
• Prepare regulatory compliance review packages with start-up CRAs when applicable.
• Maintain trial status information and country study files accurately.
• Support feasibility activities and site grant budget negotiations as required.

What you'll need

• At least 2 years of comparable experience.
• Bachelor's degree or equivalent relevant academic or vocational qualification.
• Knowledge of applicable regional and national regulatory guidelines and ethics committee regulations.
• Basic medical, therapeutic-area, and medical terminology knowledge.
• Effective oral and written communication skills.
• Strong attention to documentation detail and quality.
• Ability to work independently or in a team under direction.

Details

• Remote, North Carolina, United States.
• Standard Monday-Friday schedule.
• Work may occur in office, laboratory, or clinical environments.