FSP Country Approval Specialist – All Level

🔥 7 hours ago

🇸🇬 Singapore – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Prepare, review, and coordinate local regulatory submissions, including HSA, EC, gene therapy approvals, viral safety dossiers, and import licenses where applicable • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategies • Provide technical expertise and coordination oversight in collaboration with internal departments • Serve as primary contact for investigators and local regulatory authorities • Ensure regulatory guidelines, processes, and communications are followed • Act as key country-level contact for submission-related activities • Participate in submission, review, and project team meetings • Coordinate site start-up activities with internal functional departments and align them with submission timelines and critical paths • Lead site contract and budget negotiations with investigative sites and institutions • Independently manage complex contract and budget negotiations • Partner with Legal, Clinical Operations, Project Management, and Finance to resolve contract and budget issues • Identify, escalate, and proactively resolve contract, budget, and regulatory risks • Ensure country submission activities remain on the critical path and meet target cycle times • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project submission strategy • Develop country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budgets and payment schedule negotiations • Identify local out-of-scope contract activities and advise relevant functions • Support feasibility activities • Maintain accurate and current trial status information in the database • Oversee country study files and ensure compliance with PPD WPD or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives, and current regulatory guidelines • Direct or mentor SIA individuals assigned to projects • Identify, resolve, or escalate regulatory process issues and anomalies • Collaborate with global project teams across multiple time zones

🎯 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 • Experience working with multiple stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions • 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 • Singapore-based work location • In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient

🏖️ Benefits

• 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 • Standard office equipment will be used in accordance with company policies • Collaboration and development as part of the everyday experience • Global team environment • Standard (Mon-Fri) work schedule

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