Principal Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Lead discussions and coordinate regulatory strategies for submissions in Brazil related to Phase 1–4 clinical trials, studies, and projects.

• Provide strategic regulatory intelligence, guidance, and advisory services.

• Execute regulatory affairs service projects while collaborating with both internal and external clients.

• Prepare, compile, and review local regulatory submissions to ANVISA for pharmaceuticals, biologics, advanced therapies, and medical devices.

• Engage with sponsors, internal teams, and local regulatory authorities, including conducting meetings and presentations.

• Evaluate and analyze regulatory documents for clinical trials and relevant scientific literature.

• Act as a representative for the regulatory department across various departments.

• Contribute to business development and quality improvement efforts.

• Organize, lead, and report on meetings with regulatory agencies as a local subject matter expert.

• Assist the bidding team by providing local regulatory insights.

• Participate in meetings with local associations and engage in initiatives aimed at promoting clinical trials in Brazil.

⛳️ Requirements

• Bachelor's degree or advanced degree preferred, or an equivalent relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the necessary knowledge, skills, and abilities to perform the role effectively.

• Familiarity with both the local and global landscape of clinical trials.

• Proficiency in the English language (both written and spoken) as well as the local language.

• Exceptional attention to detail and quality, along with outstanding editorial and proofreading skills.

• Superior interpersonal skills to collaborate effectively in a team setting and serve as a liaison with other departments.

• Advanced computer skills, including Microsoft Word, Excel, and PowerPoint; ability to learn new technologies quickly.

• Strong organizational, time management, and planning abilities.

• Competence in establishing and adhering to timelines, conducting long-term planning, adapting to shifting priorities, and managing multiple projects.

• Capacity to work independently and exercise sound judgment to evaluate sponsor regulatory needs and produce compliant deliverables in association with project team members.

• In-depth understanding of national requirements and regulatory procedures for clinical trial authorization.

• Knowledge of ICH and other global regulatory frameworks.

• Strong analytical, investigative, and problem-solving capabilities.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.