Principal Regulatory Affairs Specialist

Thermo Fisher Scientific

. Lead discussions and coordinate regulatory strategies for Brazil submissions involving Phase 1–4 clinical trials, studies, and projects .

Posted 10/26/2026full-timeRemote • BrazilLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for clinical trials, including preparation and submission to ANVISA, while effectively liaising with internal teams and external clients. Possesses strong analytical and organizational skills to manage multiple projects and ensure compliance with local and global regulatory guidelines.

Highest-signal resume keywords

Regulatory Affairs ExpertiseClinical Trial Authorization KnowledgeANVISA Submission PreparationInterpersonal Communication SkillsAdvanced Computer Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy CoordinationRegulatory IntelligenceClinical Trial Document ReviewRegulatory Affairs Service ProjectsAttention to DetailProject ManagementICH Guidelines KnowledgeAnalytical SkillsProblem-Solving SkillsQuality Improvement Initiatives

Soft Skills

Exceptional Interpersonal SkillsTeam CollaborationTime ManagementAdaptabilityIndependent Judgment

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Clinical TrialsRegulatory AffairsBrazil Regulatory LandscapeDrugs and BiologicsAdvanced TherapiesRegulatory Agency MeetingsLocal Regulatory AuthoritiesSponsor LiaisonQuality ImprovementRegulatory Compliance

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule