**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** - Prepares, reviews and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. - Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines. - Ensures the submission process for sites and studies are aligned to the critical path for site activation. - Maintains contact with investigators for submission related activities; - Serves as key-contact at country level for either Ethical or Regulatory submission-related activities. - Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. - Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. - May supports the coordination of feasibility activities, as required, in accordance with agreed timelines. **Qualifications:** **Education and Experience:** Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) **Working Conditions and Environment:** • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.