Principal Regulatory Affairs Professional

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🌐 Chile, Mexico, +4 more countries – Remote

🇨🇱 Chile – Remote 🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇨🇴 Colombia – Remote 🇵🇪 Peru – Remote 🇦🇷 Argentina – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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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

• Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization • Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements • Act as liaison with internal and external clients in the provision and marketing of regulatory services • Review regulatory documents and submissions to ensure high quality standards and compliance with client, local, and regional requirements • Advise internal and external clients on regulatory strategy and provide up-to-date legislation and guidance • Participate in project management activities supporting regulatory services • Provide matrix/project leadership, training, and guidance to junior team members • Provide input on performance reviews to management • Ensure adherence to project budgets, schedules, scope of work, organizational and regulatory SOPs, and WPDs • Contribute to business development activities, including project budgeting and forecasting • Occasionally drive to site locations and travel domestically and internationally

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Excellent English language written and oral communication skills, as well as local language where applicable • Excellent attention to detail, quality, editorial, and proofreading skills • Strong interpersonal, organizational, time management, planning, negotiation, analytical, investigative, problem-solving, and independent judgment skills • Strong computer skills, including Microsoft Word, Excel, and PowerPoint, and ability to learn new technologies • Ability to manage multiple projects, changing priorities, timelines, budgets, and forecasts • Strong understanding of global, regional, and national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management • Expert knowledge of ICH and other global regulatory guidelines • Good understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing • Strong understanding of medical terminology, statistical concepts, and guidelines

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule