Description

You will ensure proper submissions and approvals for market licenses, including new registrations, changes, and renewals, while supporting regional teams and interacting with government agencies. This role is a 12-month contract with a global CRO, offering the security of a large organization with direct sponsor engagement.

Requirements

• 1-2 years experience in regulatory environment preparing submissions for Brazilian Health Authorities
• Knowledge of local international regulation and processes
• Analytical capability and investigative skills
• Self-motivated and committed to a team approach
• Desirable experience in Medical Devices or Pharma background

Responsibilities

• Elaborate regulatory strategy and execute submissions for changes, new registrations, and renewals
• Execute activities to obtain or update establishment registration licenses
• Execute post-approval activities including stakeholder communications, labels, and system updates
• Support product submission schedules, prioritization, and pipeline management
• Support internal and external audits with documentation requests