Labeling Data Remediation Specialist

Role: Labeling Data Remediation Specialist

Experience: 48 years

Key Responsibilities

• Review, validate, and correct product labeling data across systems.
• Identify gaps, inconsistencies, or missing data in existing labeling records.
• Remediate labeling fields to match regulatory standards and local market requirements.
• Ensure alignment between Regulatory submissions (e.g., eCTD, SPL), artwork, and product information.
• Support labeling data migration during system upgrades (e.g., Veeva Vault RIM, PLM, SAP).
• Collaborate with Regulatory, Quality, and Artwork teams to confirm accuracy.
• Maintain audit-ready documentation for all remediation activities.

Skills & Requirements

• Strong understanding of labeling components (SmPC, PIL, IFU, CCDS, artworks, pack labels).
• Experience in regulatory labeling or labeling operations.
• Familiarity with RIM/PLM systems (Veeva Vault RIM, Agile, SAP PLM, etc.).
• Ability to work with large datasets and detailed documentation.
• Strong attention to detail and compliance mindset.