FSP Country Approval Specialist

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 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.