Principal Regulatory Affairs Specialist

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Lead discussions and coordinate global regulatory strategies for assigned Phase 1–4 clinical trials, studies, and projects • Provide strategic regulatory intelligence, guidance, and regulatory advice • Act as a liaison with internal and external clients • Prepare and assemble global regulatory submissions, including CTAs • Interact with sponsors • Review and assess clinical trial regulatory documents and scientific literature • Manage project teams and preparation activities • Participate in launch, review, and project team meetings • Participate in bid defense meetings • Represent the regulatory department with other departments • Support business development and regulatory initiatives • Contribute to quality improvement • 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 • 8+ years of previous experience providing comparable knowledge, skills, and abilities • Knowledge of the global clinical trials landscape • Excellent command of English, written and oral, and local language where applicable • Experience with bid defense meetings • Experience leading global regulatory projects for Clinical Trial Applications • Excellent attention to detail, quality, editorial, and proofreading skills • Exceptional interpersonal skills • Advanced computer skills, including Microsoft Word, Excel, and PowerPoint • Strong organizational, time management, and planning skills • Ability to work independently and exercise independent judgment • Excellent understanding of global, regional, and national clinical trial authorization requirements and regulatory affairs procedures • Expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative, and problem-solving skills

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Equal employment opportunity and affirmative action

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