Principal Regulatory Affairs Specialist

🔥 1 minute ago

🇧🇷 Brazil – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 regulatory strategies for Brazil submissions involving Phase 1–4 clinical trials, studies, and projects • Provide strategic regulatory intelligence, guidance, and regulatory advice • Carry out regulatory affairs service projects and liaise with internal and external clients • Prepare, assemble, and review local regulatory submissions to ANVISA for drugs, biologics, advanced therapies, and devices • Interact with sponsors, internal teams, and local regulatory authorities, including meetings and audiences • Review and assess clinical trial regulatory documents and scientific literature • Represent the regulatory department with other departments • Support business development and quality-improvement initiatives • Arrange, lead, and report on regulatory agency meetings as a local expert • Support the bidding team by sharing local regulatory intelligence • Attend meetings with local associations and participate in initiatives to foster 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 the English language (written and oral) as well as local language • Excellent attention to detail and quality, plus 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; capable of learning 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 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