Global Regulatory Affairs Specialist

Job Summary

Seeking a remote, 12-month contract Global Regulatory Affairs Specialist, the candidate will coordinate and support the maintenance of labeling intelligence, ensuring compliance and alignment with business needs while managing label tracking strategies throughout the product lifecycle.

Key responsibilities

• Coordinate the labeling universe maintenance process, including analysis and tracking of updates
• Implement label tracking strategies and manage end-of-label maintenance activities
• Perform regular data quality checks and support the resolution of identified issues

Required qualifications

• Bachelor's Degree or equivalent; advanced academic qualification/degree preferred
• 8+ years of experience in a global/multi-national pharmaceutical environment, specifically in Labeling or Regulatory Affairs
• Experience with labeling intelligence systems such as PfLEET, GDMS, or PEARL
• Proficiency in Business Analytics and experience working in a matrix team environment
• Knowledge of global and local regulatory guidance around labeling and associated documentation