**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office **Job Description** + Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy; + Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients; + May have contact with investigators for submission related activities; + Key-contact at country level for either Ethical or Regulatory submission-related activities; + Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation; + Achieves PPD’s target cycle times for site; + May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable; + May develop country specific Patient Information Sheet/Informed Consent form documents; + Enters and maintains trial status information relating to start up activities onto PPD tracking databases in an accurate and timely manner; + 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. **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 2+ 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.