Associate Director, Regulatory Affairs Labeling Product Leader

Role: Associate Director, Global Labeling Product Leader within Johnson & Johnson's Innovative Medicine R&D, responsible for developing and executing global labeling strategies for pharmaceutical products. Responsibilities include leading target labeling development, collaborating with cross-functional teams (clinical, safety, regulatory, commercial), and aligning labeling strategies with global regulatory and product plans. The role involves analyzing competitor labeling, guiding local label content, managing health authority discussions, and maintaining high-quality labeling documentation. Stakeholder engagement spans global regulatory teams and external partners, with representation at governance forums like Labeling Committee. Qualifications: Bachelor's degree in a scientific discipline (advanced degree preferred), with at least 8 years of experience, including 6+ years in regulatory labeling content development, especially for pharmaceutical products and NME submissions. Experience in the pharmaceutical industry, understanding drug development processes, and familiarity with worldwide regulatory guidelines are required. Skills in scientific communication, project leadership in a matrix environment, and document management are essential. The position may involve some collaboration with external partners. Location: Hybrid, in Raritan, NJ; Titusville, NJ; or Horsham, PA.