Brazil Regulatory Affairs Consultant – Phase 3 Clinical Trial
Contract: 26 Weeks
Apply NowWe are seeking an experienced Brazilian Regulatory Affairs Consultant to support a Phase 3 clinical trial.
The immediate requirement is to provide regulatory guidance and confirm ANVISA requirements for clinical trial conduct, importation of investigational products, and local IP labeling.
The Role
Scope of Work
1. ANVISA Regulatory Submission Pathway
- Review the study protocol/synopsis and advise on the regulatory pathway in Brazil.
- Confirm requirements for clinical trial submission, importation of investigational products, and relevant ethics approvals.
- Advise on applicable submission routes, permits/licenses, and CEP/CONEP requirements.
- Provide statutory and realistic regulatory timelines.
2. IP Labeling Compliance
- Review and validate investigational product bottle labels against applicable ANVISA requirements.
- Adapt/translate existing label content into compliant Portuguese.
- Confirm mandatory local statements, sponsor/representative details, storage requirements, and lot/expiry formatting.
- Provide final regulatory sign-off on the labeling text.
Requirements
- Strong hands-on experience with ANVISA and Brazilian clinical trial regulations.
- Proven expertise in Phase 3 trials, investigational medicinal products, importation, and local labeling/packaging.
- Fluent in English and Portuguese.
- Available for hourly/time-and-materials consulting on a priority basis.
- Priority: Immediate availability preferred, as regulatory and packaging activities are on the critical path.
How to Apply
Apply Now
