FSP 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 as per applicable guidelines.

Bachelor's degree or equivalent and relevant formal academic qualification. Previous experience of 2+ years in a related field. Basic knowledge of regional/national regulatory guidelines and EC regulations.