Regulatory Affairs Analyst Consultant

Added
41 minutes ago
Type
Contract
Salary
Salary not provided

Related skills

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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