Country Approval Specialist

Prepares, reviews, and coordinates local regulatory submissions in alignment with global submission strategy. Provides local regulatory strategy advice to internal clients and coordinates with internal departments to ensure alignment of submission activities. Maintains trial status information and ensures local country study files are prepared and maintained according to applicable guidelines.

Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience of 2+ years in a related field. Strong attention to detail, effective communication skills, and basic knowledge of regional regulatory guidelines.