Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Regulatory Affairs Specialist
December 10
Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Description
• The North American Regulatory Affairs Lead provides innovative regulatory solutions for product development • Ensures client deliverables meet local, regional, and ICH regulatory and technical requirements • Oversees preparation and submission of regulatory documentation
Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) • Good English language (written and oral) communication skills as well as local language where applicable • Good attention to detail and quality as well as editorial/proofreading skills • Good interpersonal skills to work effectively in a team environment • Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Good negotiation skills • Capable of working independently with direction and exercising independent judgment • Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables • Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management • Basic understanding of medical terminology, statistical concepts, and guidelines • Good analytical, investigative and problem-solving skills • Capable of interpreting data
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