Country Approval Specialist – FSP

🕒 5 days ago

🌐 Belgium, Netherlands – Remote

🇧🇪 Belgium – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 10%

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

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 for Ministries of Health, Ethics Committees, and applicable national applications • Provide local regulatory strategy advice to internal clients under guidance • Provide and coordinate project-specific site initiation and activation services • Contact investigators regarding submission-related activities • Serve as country-level key contact for ethical or regulatory submission activities • Coordinate with internal functional departments on site start-up activities, submission activities, and timelines • Align submission processes for sites and studies with the critical path for site activation • Achieve PPD target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheets and Informed Consent forms when applicable • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activities according to agreed timelines • Enter and maintain trial status information for site initiation and activation activities in PPD tracking databases • Prepare, establish, and maintain local country study files and filing processes according to PPD work practice documents or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives, and applicable regulatory guidelines

🎯 Requirements

• Knowledge of country submission requirements for Belgium and the Netherlands • Knowledge of English and Dutch and/or French • Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 2+ years of previous experience, or comparable knowledge, skills, and abilities • 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 English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations • Ability to work in office/laboratory and/or clinical environments • Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Personal protective equipment such as protective eyewear, garments, and gloves

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