FSP Country Approval Specialist, All Level

🔥 2 hours ago

🇸🇬 Singapore – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Prepare, review, and coordinate local regulatory submissions, including HSA, EC, gene therapy approvals, viral safety dossiers, and import licenses • 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 submission guidelines, processes, and communications are followed • Act as country-level key 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 the critical path for site activation • 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 issues • Identify, escalate, and resolve contract, budget, and regulatory risks • Ensure country submission activities meet target cycle times and remain on the study start-up critical path • Prepare regulatory compliance review packages • Coordinate local submission activity within SIA according to global project 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 for compliance with PPD WPD or client SOPs • Maintain knowledge of SOPs, client directives, and current regulatory guidelines • Direct or mentor other SIA team members • Identify, resolve, or escalate regulatory process issues and anomalies

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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 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 • Ability to mentor fellow SIA team members • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations • Proficiency in Microsoft Office and clinical trial management systems

🏖️ Benefits

• Fully remote work arrangement • Occasional travel for investigator meetings, sponsor meetings, or business needs • Home office environment • Standard office equipment • Collaboration and development opportunities • Global team environment • Passion, innovation, and commitment to scientific excellence

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