Country Approval Specialist

Country Approval Associate position supporting preparation and coordination of regulatory submissions for clinical trials. Reports to regulatory leadership and collaborates across functional departments to ensure timely site activation and compliance with global submission strategy.

Responsibilities

• Prepare, review, and coordinate country submissions and local Ministry of Health submissions aligned with global strategy
• Coordinate with internal departments to align site start-up activities with submission timelines and critical path requirements
• Develop and assist with country-specific informed consent forms and patient information documents
• Maintain trial status information in tracking databases and ensure local country study files comply with standard operating procedures
• Support grant budget negotiations and payment schedules with clinical sites

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 0-2 years relevant experience in regulatory or clinical trial operations
• Strong written and oral communication abilities
• Proficiency with computer systems and software learning capability
• Knowledge of regional and national regulatory guidelines
• Attention to detail and quality documentation practices