Senior Manager, Regulatory Affairs Labeling Product Leader

Role: Senior Manager, Regulatory Affairs Labeling Product Leader in Johnson & Johnson's Innovative Medicine division, responsible for developing and executing global labeling strategies for pharmaceutical products. Key responsibilities include leading target labeling development, collaborating with cross-functional teams (clinical, safety, market access, medical), and managing health authority interactions to ensure compliant, scientifically accurate labeling aligned with product strategy. The role involves analyzing competitor labeling, providing strategic guidance for local labeling in major markets, and maintaining primary and derived labeling documents such as CCDS, USPI, and EUPI. It also encompasses leading labeling working groups, representing labeling in regulatory teams, and supporting inspections and audits. Qualifications include a minimum of an 8-year professional regulatory experience with at least 6 years in pharmaceutical labeling, a scientific bachelor’s degree (advanced degrees preferred), and knowledge of worldwide regulatory guidelines. Prior experience with target labeling development, NME submissions, and working within matrix environments is required. The role demands excellent communication, organizational, and negotiation skills, with the ability to manage multiple complex projects independently. High-value biopharma specifics include focus on pharmaceutical development, regulatory compliance, and global labeling strategies. This hybrid position is located in the U.S. (Raritan, Horsham, Titusville) with potential collaboration with external partners.