Sr. Associate, Labeling

Coordinates Master Labeling Content review and approval for new and revised content. Supports the GRA strategist (Project/Product owner) on required content changes and executes revisions to Master Labeling Content document. Coordinates with Labeling Head and stakeholders to ensure consistency across product labeling and incorporate updated /revised global and /or country specific labeling requirements. For products with updated Master Labeling Content, reviews and approves revisions to labeling components. Provides input to regulatory assessments and change request bundling evaluations for labeling and coordinates GRA strategist to complete RIARS. Initiates portfolio-wide label change requests based on regulatory intelligence and other external input. Propagates labeling requirements knowledge sharing in functions beyond GRA.

Also supports E2E translations management with country regulatory teams and third-party vendors.

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