Job Title

ANALYST REGULATORY AFFAIRS Consultant

Job Summary

Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

Major Roles and Responsibilities

• Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.
• Execute activities to obtain or update establishment registration licenses.
• Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
• Request and follow-up of documentation to prepare registration dossiers.
• Supports regional team on product submissions schedules, prioritization, and pipeline management.
• Support internal and external audits with documentation request...