Country Approval Assoc

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 site start-up activities align with submission activities. Maintains trial status information and ensures local study files are prepared and maintained according to applicable guidelines.

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