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Regulatory Labeling Mgr

HyderabadFull-timeJunior levelPosted over a month ago

Legal role at Amgen in Hyderabad.

About the role

Regulatory Labeling Manager will support the planning, coordination, and execution of EU and global labelling compliance activities within the Regulatory Affairs organisation. This role will support end-to-end labelling activities, including Product Information updates, linguistic review, mock-up coordination, artwork review, approval workflows, and implementation of approved labelling changes.

What you'll do

  • Coordinate day-to-day labelling activities to support timely and compliant implementation of approved labelling changes across EU and global markets
  • Ensure labelling updates are aligned with approved Product Information, internal procedures, quality standards, and market-specific implementation requirements
  • Identify potential compliance risks, delays, inconsistencies, or documentation gaps and escalate issues to the appropriate stakeholders for timely resolution

What you need

  • Compliance
  • Regulatory affairs
  • Documentation

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