Country Approval Specialist-Korea-FSP dedicated

The Country Approval Specialist will manage the preparation, review, and coordination of country submissions according to global strategies, including local regulatory submissions for various applications. They will provide local regulatory strategy advice to internal clients, develop and implement local submission strategies, and offer technical expertise and coordination for projects. This role involves serving as the primary contact for investigators and local regulatory authorities, ensuring timely management of submissions and maintaining effective communication. The specialist will also coordinate with internal departments for site start-up activities, ensuring alignment with submission timelines and critical path for site activation, and achieve client target cycle times for site activations. Additionally, they will prepare regulatory compliance review packages, assist with grant budget negotiations, identify and advise on out-of-scope activities, and maintain knowledge of PPD and Client SOPs and current regulatory guidelines.