Associate Director, Regulatory Affairs Labeling Product Leader

Role: Associate Director, Global Labeling Product Leader within Johnson & Johnson's Innovative Medicine R&D, responsible for leading global labeling strategies for pharmaceutical products. Responsibilities include developing target and primary labeling in collaboration with regulatory, clinical, safety, and commercial teams, and ensuring alignment with global regulatory guidelines. The role entails leading labeling development for new molecular entities, managing labeling content across regions, and representing labeling in cross-functional governance. Additionally, it involves strategic health authority negotiations, preparing contingency plans, and supporting inspections. Qualifications: Bachelor's degree in a scientific discipline (advanced degree preferred), at least 8 years of professional experience with 6+ years in regulatory labeling, and familiarity with drug development and worldwide regulatory standards. Experience with target labeling for NMEs and document management systems is required. Preferred skills include regulatory compliance, strategic thinking, and effective communication. High-Value: Focus on pharmaceutical products, including biologics or small molecules, involved in regulatory submissions and global market labeling. The role is hybrid, based in Raritan, NJ, Titusville, NJ, or Horsham, PA, with no specific travel requirements stated.