[Remote] Sr. Ctry Approval Spec at Thermo Fisher Scientific

The Sr. Ctry Approval Spec is responsible for managing the preparation, review, and coordination of country submissions in alignment with global submission strategies. This includes preparing and reviewing local regulatory submissions, providing local regulatory strategy advice, and developing and implementing local submission strategies. The role involves coordinating with internal departments to provide technical expertise and oversight for projects, serving as the primary contact for investigators and local regulatory authorities, and ensuring adherence to guidelines and processes for effective communication. The individual will act as a key contact for all submission-related activities at the country level, participate in various meetings, and coordinate with internal functional departments to align site start-up activities with submission timelines. Responsibilities also include preparing regulatory compliance review packages, liaising with local SIA teams, developing country-specific Patient Information Sheet/Informed Consent form documents, assisting with grant budget negotiations, identifying and advising on out-of-scope contract activities, supporting feasibility activities, maintaining accurate trial status information, overseeing country study files to meet SOPs, and maintaining knowledge of applicable SOPs and regulatory guidelines. The role may also involve directing and mentoring other SIA individuals and proactively identifying and resolving or escalating issues within the regulatory process.