Principal Regulatory Affairs Specialist
About The Position
The Principal Regulatory Affairs Specialist joins the global Regulatory Affairs department and leads discussions and coordinates regulatory strategies for submissions in Brazil for assigned Phase 1–4 clinical trials, studies, and projects. The role contributes local regulatory expertise and strategic guidance to internal teams and, when needed, clients, while serving as a liaison with internal and external stakeholders. The specialist also represents Regulatory Affairs across departments, supports business development and quality-improvement initiatives, and arranges, leads, and reports on regulatory agency meetings as a local expert.
Requirements
- Bachelor's degree or an advanced degree preferred, or equivalent relevant formal academic or vocational qualification.
- Previous experience providing 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, and excellent editorial and 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, and ability to learn new technologies.
- Strong organizational, time-management, and planning skills, including creating and following timelines, conducting long-range planning, adapting to changing priorities, and handling multiple projects.
- Ability to work independently and exercise independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables.
- Strong understanding of national country requirements and regulatory affairs procedures for clinical trial authorization, and knowledge of ICH and other global regulatory guidelines.
- Good analytical, investigative, and problem-solving skills.
Responsibilities
- Prepare, assemble, and review local regulatory submissions to ANVISA related to clinical development dossiers and clinical trial applications for drugs, biologics, advanced therapies, and devices.
- Discuss regulatory strategy for each project.
- Interact with sponsors and internal teams.
- Interact with local regulatory authorities, including through meetings and audiences.
- Review and assess clinical trial regulatory documents.
- Review and assess scientific literature.
- Support the bidding team by sharing local regulatory intelligence.
- Attend meetings with local associations and participate in initiatives to foster clinical trials in Brazil.
- Arrange, lead, and report on regulatory agency meetings.
- Represent the Regulatory Affairs department with other departments, support business development, work on initiatives, and contribute to quality improvement.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
