[Remote] Sr Ctry Approval Spec at Thermo Fisher Scientific

The Sr Ctry Approval Spec prepares, reviews, and coordinates local regulatory submissions, including those to the Ministry of Health and Ethics Committees, aligning with global strategies. They provide local regulatory strategy advice, coordinate country-specific submission services, and act as the key country contact for regulatory activities. This role involves coordinating with internal departments for site start-up activities, ensuring alignment with submission timelines and critical path for site activation. Responsibilities also include maintaining trial status information, managing local country study files, and staying knowledgeable about relevant Standard Operating Procedures and regulatory guidelines.