Senior Regulatory Affairs Specialist – CTA, Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• Join the global Regulatory Affairs department as a Senior Regulatory Affairs Specialist • Lead discussions and coordinate regulatory strategies globally on assigned clinical trials • Provide innovative solutions and global regulatory expertise • Act as a 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 the knowledge, skills, and abilities to perform the job • Knowledge of the global clinical trials landscape • Excellent command of the English language (written and oral) as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills

🏖️ Benefits

• competitive salary • extensive benefits package centered on employee health and well-being • flexible working culture • emphasis on work-life balance