Global Labeling Operations Manager

Job Summary

Driving global labeling strategy, the contract Global Labeling Operations Manager will lead end-to-end labeling operations, ensuring compliance and high-quality documentation while working remotely.

Key responsibilities

• Serve as primary liaison between Regulatory/Labeling and Artwork/Change Management teams to align activities and timelines
• Lead Structured Product Labeling (SPL) management and coordinate vendor delivery of SPL submissions to the FDA
• Maintain labeling SOPs, oversee compliance version control, and support internal audits and regulatory inspections

Required qualifications

• 3+ years of experience in the pharmaceutical/biotechnology industry, with a minimum of 2 years in regulatory labeling
• Solid understanding of regulatory labeling guidelines, pharmacology, and drug development lifecycles
• Hands-on experience with document management and regulatory tracking systems
• Bachelor's degree in a scientific or medically related discipline is preferred