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Principal Regulatory Affairs Specialist – Global Clinical Trial Applications
Thermo Fisher ScientificPrincipal Regulatory Affairs Specialist enabling global clinical trial applications at Thermo Fisher Scientific. Leading regulatory strategies and liaising with clients for regulatory affairs services.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- award-winning learning and development programme
- health and well-being of employees
- flexible working culture
- collaborative environment
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesclinical trialsregulatory expertiseclinical trial applicationsattention to detaileditorial skillsanalytical skillsproblem-solving skills
Soft Skills
interpersonal skillsorganizational skillstime managementplanning skillscommunication skills
Certifications
Bachelor's degreeadvanced degree