Back to jobsAssist in preparing and reviewing submission packages in compliance with Health Canada regulations, including Administrative and Labelling Only submissions.
Support regulatory tasks related to product rebranding initiatives, conducting gap analyses between existing and proposed labels & Labeling revisions.
Review labels, cartons, inserts, and Prescribing Information for compliance.
Compiling rebranding submission documentation (updated mock-ups, attestations etc.)
Facilitating internal artwork routing and regulatory approval steps.
Work closely with Quality Assurance, Marketing, Supply Chain, and Packaging/Artwork teams.
Support regulatory input during product changes, rebranding workflows, and market readiness projects.
Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
Participate in project meetings to help ensure regulatory compliance across product lifecycles.
