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Principal Regulatory Affairs Specialist – Global Clinical Trial Applications
Location
Serbia
Posted
59 days ago
Salary
0
Seniority
Lead
Job Description
Principal Regulatory Affairs Specialist – Global Clinical Trial Applications
Thermo Fisher Scientific
• 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
Job 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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