Associate Director, Regulatory Affairs Labeling Product Leader

Role: Associate Director, Global Labeling Product Leader within Johnson & Johnson’s Innovative Medicine R&D, leading global labeling strategy and development for assigned products. Responsibilities: drive labeling strategy aligned with regulatory and product objectives; lead target and primary labeling development, revisions, and approval processes; collaborate cross-functionally with clinical, safety, market access, and medical teams; communicate with Health Authorities; and support labeling inspections and audits. Requirements: Bachelor’s in a scientific discipline (advanced degree preferred); 8+ years of pharmaceutical regulatory experience with at least 6 years focused on labeling content development and review; knowledge of worldwide regulatory guidelines; experience managing complex projects and cross-functional teams; excellent communication and organizational skills. High-Value: experience with target labeling development or NME submissions; familiarity with global labeling standards, risk mitigation, and regulatory interactions; ability to manage multiple products and projects independently; strong scientific communication skills. WorkSetup: Hybrid in Raritan, NJ; Titusville, NJ; or Horsham, PA; with potential external collaboration. Travel not explicitly stated.