Principal Regulatory Affairs Specialist

• 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

• 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

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