Associate Director, Regulatory Affairs Labeling Product Leader

Role: Associate Director, Global Labeling Product Leader within Johnson & Johnson's Innovative Medicine R&D, responsible for shaping global labeling strategies for pharmaceutical products. Primary objectives include developing target and primary labeling, leading cross-functional labeling teams, and ensuring alignment with global regulatory requirements and product strategies. Responsibilities encompass leading label development, competitor analysis, health authority discussions, and maintaining high-quality compliant labeling documents. The role involves strategic collaboration with regulatory, clinical, safety, market access, and medical teams, and representing global labeling in regulatory and cross-functional forums. Qualifications: Bachelor's degree in a scientific discipline (advanced degree preferred), minimum 8 years' professional experience, with at least 6 years in regulatory labeling content development, especially for pharmaceutical products or NMEs. Experience with target labeling development, global regulatory guidelines, and working in matrix teams is required. Skills include scientific communication, project management, negotiation, and regulatory acumen. High-value specifics: focus on pharmaceutical products in innovative medicine, global regulatory labeling strategy, and cross-functional leadership. The position is hybrid, based in Raritan, NJ, Titusville, NJ, or Horsham, PA, with an emphasis on collaboration and strategic influence in drug labeling.