Senior Country Approval Specialist

The Senior Country Approval Specialist will manage the preparation, review, and coordination of country submissions according to global strategy. They will provide local regulatory strategy advice to internal clients, develop and implement local submission strategies, and offer technical expertise. The role involves serving as the primary contact for investigators and local regulatory authorities, ensuring timely submissions and adherence to guidelines. Responsibilities also include coordinating site start-up activities with submissions, achieving target cycle times for site activations, preparing regulatory compliance review packages, and developing country-specific patient information and informed consent documents.