Principal Regulatory Affairs Specialist
Core
Lead regulatory strategies and coordinate submissions for Phase 1-4 clinical trials, studies, and projects for drugs, biologics, advanced therapies, and devices in Brazil.
Role type
Principal Regulatory Affairs Specialist
Builds
Regulatory submissions and strategies for clinical development dossiers
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, clinical trial authorization, ANVISA submissions, ICH guidelines, scientific literature review, regulatory intelligence, meeting management
Preferred skills
Advanced degree, local language fluency
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Prepare and review local regulatory submissions to ANVISA, discuss regulatory strategy for each project, interact with sponsors and internal teams, interact with local regulatory authorities, review clinical trial regulatory documents, support the bidding team with local regulatory intelligence, attend meetings with local associations