Labeling Data Remediation Specialist

Role : Labeling Data Remediation Specialist

Experience : 4–8 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.