Responsibilities

The Country Approval Specialist (SSU) will manage the preparation, review, and coordination of Country Submissions, aligning them with global submission strategies. They will prepare and coordinate local regulatory submissions (EC, and other national applications) in line with these strategies, providing local regulatory strategy advice. The role involves developing and implementing local submission strategies, serving as a primary contact for investigators and regulatory authorities, ensuring timely submissions, and coordinating with internal departments to align site start-up activities with submission timelines.