Country Approval Specialist

🔥 25 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 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 Ministry of Health, Ethics Committee, gene therapy approvals, viral safety dossiers and import licenses • Provide local regulatory strategy advice to internal clients • Provide project-specific local start-up services and coordinate these projects • Contact investigators for submission-related activities as needed • Serve as the country-level key contact for ethical or regulatory submission activities • Coordinate with internal functional departments to align site start-up and submission activities with agreed timelines and site-activation critical paths • Achieve target cycle times for site activation • Prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budget and payment schedule negotiations with sites when needed • Support feasibility activities in accordance with agreed timelines • Enter and maintain trial status information in study-specific tracking databases accurately and timely • Prepare, set up and maintain local country study files and filing processes according to applicable SOPs • Maintain knowledge of and understand SOPs, client directives and current regulatory guidelines applicable to provided services

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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