FSP Country Approval Specialist (all level)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 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.