FSP Country Approval Specialist (all level)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation The 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 (HSA, 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 (HSA &/or EC) to internal clients. • Develop and implement local submission strategy. Provide 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. • Lead site contract and budget negotiations with investigative sites and institutions, ensuring timely execution while maintaining compliance with sponsor requirements, local regulations, and company standards. • Independently manage complex contract and budget negotiations, balancing study timelines, financial objectives, and site relationship management. • Partner closely with Legal, Clinical Operations, Project Management, and Finance to resolve contract and budget issues that may impact study timelines. • Identify, escalate, and proactively resolve contract, budget, and regulatory risks that could delay site activation. • Ensure country submission activities remain on the critical path for study start-up and achieve target cycle times. • Prepare the regulatory compliance review packages, as applicable. • Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. • 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 PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate • Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate. Education & Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Minimum 3-5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry. • Demonstrated experience independently managing site contract and budget negotiations is required. • Experience working with multiple stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions. 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: • Strong experience in site contract and budget negotiation with hospitals and investigative sites. • Solid understanding of clinical trial agreements , site budget development, and negotiation strategies. • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • 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 • Basic organizational and planning skills • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations • Proficiency in Microsoft Office and clinical trial management systems. Working Conditions and Environment: • This is a fully remote position based in Singapore. • Occasional travel may be required for investigator meetings, sponsor meetings, or business needs. • Work is primarily performed in a home office environment with frequent interaction with global • project teams across multiple time zones. • Standard office equipment will be used in accordance with company policies. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a…