Senior Regulatory Affairs Specialist

April 16

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Thermo Fisher Scientific

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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.

Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Serves as a senior contact within the Global Central Labs at CRG, Thermo Fisher Scientific, providing innovative solutions and regulatory expertise. • Interacts with clients to offer strategic regulatory intelligence and guidance ensuring compliance with FDA/IVDR, CE regulations as well as CAP and CLIA standards. • Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. • Acts as a liaison with internal and external clients in the provision and marketing of these specialized laboratory services. • Prepares and reviews regulatory guidance. • Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies. • Leads the development and implementation of project-specific processes for sponsors. • Collaborates extensively with other departments, regulatory consultants, and regulatory authorities. • Provides training and guidance to junior team members as appropriate. • Participates in project launch meetings, review meetings and project team meetings. • Supports business development activities to advise on regulatory implications for project delivery

🎯 Requirements

• Bachelor's degree or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • Strong English language (written and oral) communication skills as well as local language where applicable • Solid attention to detail and quality as well as strong editorial/proofreading skills • Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Solid negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc. • Solid understanding of medical terminology, statistical concepts, and guidelines • Strong analytical, investigative and problem-solving skills • Working knowledge of budgeting and forecasting

🏖️ Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • a range of employee benefits