인재풀 - Country Approval Specialist (SSU)

Responsibilities

The Country Approval Specialist will manage the preparation, review, and coordination of Country Submissions in alignment with global submission strategy, providing local regulatory strategy advice to internal clients. They will develop and implement local submission strategy, serve as a primary contact for investigators and regulatory authorities, ensure adherence to guidelines and processes, participate in meetings, coordinate with internal departments, and oversee country study files to maintain compliance and timely submissions. Additionally, the role involves developing Patient Information Sheet/Informed Consent form documents, assisting with grant budgets and payment schedules, and proactively identifying and resolving regulatory issues.