Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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.
Principal Regulatory Affairs Specialist – Global Clinical Trial Applications
Job not on LinkedIn
🕒 April 23
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Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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
• Enabling customers to make the world healthier, cleaner and safer • Join global Regulatory Affairs department, Reg Science team • Lead discussions, coordinate regulatory strategies globally on assigned clinical trials • Provide innovative solutions and global regulatory expertise • Act as liaison with internal and external clients • 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 • Previous experience that provides knowledge, skills, and abilities to perform the job comparable to 8+ years • Knowledge of the global clinical trials landscape • Excellent command of the English language (written and oral) • Experience with Bid Defense meetings • Experience in leading global regulatory projects for Clinical Trial Applications • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment • Advanced computer skills including the use of Microsoft Word, Excel, Power Point • Strong organizational, time management, and planning skills • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization • Excellent analytical, investigative and problem-solving skills
🏖️ Benefits
• award-winning learning and development programme • health and well-being of employees • flexible working culture • collaborative environment
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