Regulatory Affairs Labeling Specialist

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Skills you'll use

What you'll do

• Support Regulatory Labeling Leads in managing labeling compliance activities and tracking deviations from Company Core Data Sheets (CCDS).
• Maintain safety variation trackers, labeling compliance trackers, and other regulatory documentation.
• Contribute labeling inputs for annual reports and periodic safety reports (PBRER/PADER) for assigned products.
• Conduct competitor labeling analysis using digital tools, including AI-enabled applications.
• Perform quality control reviews for EU linguistic reviews and localization activities for SmPCs and Package Leaflets.
• Format, hyperlink, proofread, and quality check CCDS, USPI, and SmPC documents according to regulatory standards and checklists.
• Perform text comparison, annotation reviews, and cumulative redline preparation for labeling updates.
• Create and coordinate Structured Product Labeling (SPL) development, validation, and regulatory submissions.
• Support packaging update activities and associated Veeva workflows.
• Manage labeling workflows within Veeva and support system updates, testing, and process improvements.

Who can apply

• Familiarity with Structured Product Labeling (SPL), labeling quality control, and submission processes.

About Regeneron

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