FSP Country Approval Specialist

Overview

Manage and coordinate country-level regulatory and ethical submissions for clinical study start-up activities in Romania.

What you'll do

• Prepare, review, and coordinate local regulatory submissions.
• Provide local regulatory strategy advice to internal clients.
• Coordinate country-level study start-up services and activities.
• Align submission activities with site activation timelines.
• Prepare regulatory compliance review packages and informed consent documents.
• Maintain trial status information in study tracking databases.
• Set up and maintain country study files according to applicable procedures.

What you'll need

• Bachelor's degree or equivalent relevant qualification.
• At least 2 years of comparable experience.
• Strong oral and written English communication skills.
• Knowledge of medical terminology and therapeutic areas.
• Knowledge of applicable regulatory guidelines and ethics committee regulations.
• Strong attention to documentation quality and detail.
• Ability to work independently or in a team environment.

Details

• Remote role in Romania.
• Standard Monday–Friday schedule.
• Office-based working conditions.