Labeling Data Remediation Specialist

8 years

0 Lacs

Posted:3 weeks ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role: Labeling Data Remediation Specialist

Experience:


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.

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