Regulatory Labeling Manager – Artwork Development And Source Text Review (Latam Only) (Bogotá)

Position Summary

The Labeling Artwork Reviewer is responsible for the review and approval of pharmaceutical labeling artwork to ensure compliance with regulatory requirements, internal standards, and market‑specific guidelines.

Key Responsibilities

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
• Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
• Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
• Training and oversight of additional FSP resources for artwork management.
• Ensure compliance with country‑specific regulatory requirements, including FDA, EMA, and other global hea...