Senior Regulatory Affairs Specialist - FSP - EMEA

🔥 17 hours ago

🌐 Bulgaria, France, +4 more countries – Remote

🇧🇬 Bulgaria – Remote 🇫🇷 France – Remote 🇵🇹 Portugal – Remote 🇮🇹 Italy – Remote 🇪🇸 Spain – Remote 🇺🇦 Ukraine – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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

• Serve as lead over several countries/projects, providing regulatory expertise and client interface • Review country-level essential documents for completeness, accuracy, and quality according to the study-specific Essential Document Compliance checklist • Review site-level essential documents for completeness, accuracy, and quality • Notify the EDP Submitter by email of review outcomes, requested revisions, and corrected documents when deficiencies are identified • Review revised document packs to ensure deficiencies are resolved • Communicate review outcomes to the SSU Specialist • Track EDP review details in the applicable data tracking system • Maintain knowledge of SOPs, client SOPs/directives, and current regulatory guidelines • Support timely site activation

🎯 Requirements

• Good English language (written and oral) communication skills, as well as local language where applicable • Good attention to detail and quality • Editorial/proofreading skills • Good interpersonal skills to work effectively in a team environment • Good computer skills, including Microsoft Word, Excel, and PowerPoint • Ability to learn new technologies • Basic organizational, time management, and planning skills • Ability to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects • Good negotiation skills • Ability to work independently with direction and exercise independent judgment • Bachelor's degree or previous experience comparable to 2+ years

🏖️ Benefits

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