.At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.**Location/Division Specific Information****Discover Impactful Work**:Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.**A day in the Life**:- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.- Provides project specific local Start Up services and coordination of these projects.- 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.- May assist with grant budgets(s) and payment schedules negotiations with sites.- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.- 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.**Keys to Success**:**Education**- Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role