Regulatory Affairs Labeling

About the role

We are seeking a Regulatory Labeling Specialist to join our team in a remote capacity. As a Regulatory Labeling Specialist, you will ensure that medicinal product information remains accurate, compliant, and current throughout its lifecycle. Accurate labeling helps patients and healthcare professionals get the information they need about medicines.

What you'll do

• Perform regulatory impact assessments for change controls raised in TrackWise for medicinal products registered via the Centralized Procedure (CP)
• Manage product information updates, including creation and updates of the Company Core Data Sheet (CCDS), applying clinical expertise
• Prepare and submit variations, notifications, and renewals to Health Authorities
• Respond to Health Authority questions on submissions
• Coordinate labeling updates, including translations, with team members and client stakeholders

What you need

• 6–11 yrs of experience
• Regulatory affairs
• Chemistry
• Clinical research
• Communication
• B.Sc