Regulatory Affairs Manager – Global Clinical Trial Applications

🔥 2 hours ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 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

• Join Thermo Fisher Scientific’s global Regulatory Affairs department and Regulatory Science team • Provide innovative regulatory solutions and own regulatory affairs responsibilities • Lead discussions with internal and external clients • Coordinate global regulatory strategies on assigned Phase 1–4 clinical trials, studies, and projects • Support clients with strategic regulatory intelligence and guidance throughout clinical development • Lead preparation of global regulatory submissions for clinical trial applications (CTA) • Ensure submissions meet local and regional requirements and high quality standards • Provide regulatory strategy advice and technical expertise for internal and external clients and key projects • Oversee multiple studies/projects, ensuring alignment of regulatory strategy, quality, and delivery • Serve as a senior client-facing lead in regulatory planning, proposals, bid defenses, and scope discussions • Ensure quality performance for key/managed projects • Manage project budgeting and forecasting, including financial and scope accountability • Identify out-of-scope activities and partner with relevant teams on contract modifications • Collaborate with business development on pricing and securing new business • Contribute to proposals, budgets, and client presentations • Provide matrix/project leadership and guidance to team members • Ensure compliance with organizational and regulatory SOPs and WPDs • Participate in launch, review, and project team meetings

🎯 Requirements

• Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 9+ years) • Proven project management experience • Experience performing effectively in a client-facing role • Strong understanding of global/regional regulatory requirements and ICH guidelines • Excellent analytical, investigative, and problem-solving skills • Solid understanding of budgeting and forecasting • Excellent English language (written and oral) communication skills, as well as local language where applicable • Excellent attention to detail and quality, with strong editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including Microsoft Word, Excel, and PowerPoint • Strong organizational, time management, and planning skills • Excellent negotiation skills

🏖️ Benefits

• Competitive salary • Extensive benefits package focused on health and well-being • Flexible working culture • Work-life balance valued • Collaborative global environment • Opportunities for growth and development

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