Senior Country Approval Specialist

The Senior Country Approval Specialist will manage the preparation, review, and coordination of country submissions, including MoH and EC applications, in alignment with global strategies. They will provide local regulatory strategy advice, develop and implement submission strategies, and serve as the primary contact for investigators and local regulatory authorities to ensure timely submissions. Responsibilities also include coordinating with internal departments for site activation, developing country-specific patient information and informed consent documents, and ensuring compliance with guidelines and processes.