Principal Country Approval Specialist (PCAS，PSSU)

Job description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Join Us as a Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: • Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provide local regulatory strategy advice (MoH & EC) to internal clients. • Provide project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments. • Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner. • Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner. • Act as a key-contact at country level for all submission-related activities. • Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. • Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieves company’s target cycle times for site activations. • Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • Develop country specific Patient Information Sheet/Informed Consent form documents. • May assist with grant budgets(s) and payment schedules negotiations with sites. • Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. • Support the coordination of feasibility activities, as required, in accordance with • agreed timelines. • Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. • Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s. • Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Direct/mentor other SIA individuals assigned to support projects of responsibility, as appropriate. • Prepare and maintain country master document templates and other regulatory intelligence systems, as may be required and assigned. Education & Experience Requirements: • 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 8+ 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. Knowledge, Skills, Abilities: • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Solid negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Good judgment and decision-making skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision, as required • Ability to mentor fellow SIA team members in a positive and effective manner • Excellent team player with teambuilding skills • Good organizational and planning skills • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations 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. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.