Principal Regulatory Affairs Specialist

🔥 2 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Lead regulatory affairs responsibilities, discussions, and regulatory strategies for Brazil submissions on assigned Phase 1–4 clinical trials, studies, and projects • Provide strategic regulatory intelligence, guidance, and regulatory advice to internal team members and clients • Carry out regulatory affairs service projects and act as liaison with internal and external clients • Represent the regulatory department with other departments • Support business development and departmental initiatives • Contribute to quality improvement • Arrange, lead, and report on regulatory agency meetings as a local expert • Prepare, assemble, and review local regulatory submissions to ANVISA for clinical development dossiers and clinical trial applications covering drugs, biologics, advanced therapies, and devices • Discuss regulatory strategy for each project • Interact with sponsors, internal teams, and local regulatory authorities, including meetings and audiences • Review and assess clinical trial regulatory documents and scientific literature • Support the bidding team by sharing local regulatory intelligence • Attend meetings with local associations and participate in initiatives fostering clinical trials in Brazil

🎯 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 local and global clinical trials landscape • Excellent command of English, written and oral, as well as the local language • Excellent attention to detail and quality • 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 Microsoft Word, Excel, and PowerPoint • Ability to learn new technologies • Strong organizational, time management, and planning skills • Ability to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects • Ability to work independently and exercise independent judgment • Ability to assess sponsor regulatory needs and produce compliant deliverables with project team members • Strong understanding of national country requirements and regulatory affairs procedures for clinical trial authorization • Knowledge of ICH and other global regulatory guidelines • Good analytical, investigative, and problem-solving skills

🏖️ Benefits

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

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