Principal Regulatory Affairs Specialist – Global Clinical Trial Applications

🔥 16 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

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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

• Lead discussions and coordinate global regulatory strategies for assigned Phase 1–4 clinical trials, studies, and projects • Provide strategic regulatory intelligence, guidance, and advice to clients • Perform regulatory affairs projects and services • Act as liaison with internal and external clients • Prepare and assemble global Clinical Trial Application regulatory submissions • Interact with sponsors • Review and assess clinical trial regulatory documents and scientific literature • Manage project teams and preparation • Participate in launch, review, and project team meetings • Participate in bid defense meetings • Represent the regulatory department with other departments • Support business development and departmental initiatives • Contribute to quality improvement • Arrange, lead, and report on client and regulatory agency meetings

🎯 Requirements

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing comparable knowledge, skills, and abilities • Knowledge of the global clinical trials landscape • Excellent command of English, written and oral, and local language where applicable • Experience with bid defense meetings • Experience leading global regulatory projects for Clinical Trial Applications • Excellent attention to detail, quality, editorial, and proofreading skills • Exceptional interpersonal skills for teamwork and liaison with other departments • Advanced computer skills including Microsoft Word, Excel, and PowerPoint • Ability to learn new technologies • Strong organizational, time management, and planning skills • Ability to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects • Ability to work independently and exercise independent judgment • Excellent understanding of global, regional, and national clinical trial authorization requirements and regulatory affairs procedures • Expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative, and problem-solving skills

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive health and well-being benefits package • Flexible working culture • Work-life balance • Collaborative environment • Global organization with a local feel

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