Regulatory Affairs Labeling
Core
Ensure medicinal product information remains accurate, compliant, and current throughout its lifecycle, supporting regulatory impact assessments and Health Authority submissions.
Role type
Regulatory Labeling Specialist
Builds
Product information updates, Health Authority submissions, and post-approval compliance activities
Domain
Life Sciences / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory impact assessment, Product information management, Health Authority submission preparation, Variation and notification management, Labeling update coordination, Post-approval activity management
Preferred skills
xEVMPD experience
Technologies
Veeva RIMS, TrackWise
Responsibilities
Perform regulatory impact assessments for change controls; Manage product information updates including Company Core Data Sheet creation; Prepare and submit variations, notifications, and renewals to Health Authorities; Respond to Health Authority questions on submissions; Coordinate labeling updates including translations; Manage post-approval activities in Veeva RIMS
Seniority
Mid-Senior, hands-on IC