Principal Regulatory Affairs Specialist

Prepare, assemble and review local regulatory submissions to ANVISA related to clinical development dossiers and clinical trial applications. Discuss regulatory strategy for each project and interact with sponsors and internal teams. Review and assess clinical trial regulatory documents and scientific literature, and support the bidding team by sharing local regulatory intelligence.

Bachelor's degree or advanced degree preferred. Previous experience in regulatory affairs with knowledge of the local and global clinical trials landscape. Excellent command of English and local language, advanced computer skills including Microsoft Office, and strong understanding of national regulatory affairs procedures.

Remote work arrangement with a standard Monday to Friday schedule. Opportunity to develop regulatory career and expertise within a global team.