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audit gmp regulatory submissions labeling anvisa📋 Description
- Ensure timely submission and approvals for market licenses (new registrations, changes, renewals)
- Manage establishment registration licenses and updates
- Handle post-approval tasks: stakeholder communications, labels, and Instructions for Use updates
- Gather and follow up documents to prepare registration dossiers
- Support regional submissions schedules and pipeline management
- Assist internal and external audits with documentation requests
🎯 Requirements
- 1-2 years in regulatory environment; submissions to Brazilian health authorities
- Desirable: medical devices or pharma background
- Bachelor's in Engineering, Pharmacy or life sciences; fluent in Portuguese; English reading/writing
- Knowledge of local and international regulation and processes
- Analytical, planning, and project management; Excel data handling
- Strong communication, teamwork; ability to meet deadlines and sense of urgency
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