Senior Manager, Regulatory Affairs Labeling Product Leader

Role: Senior Manager, Regulatory Affairs Labeling Product Leader at Johnson & Johnson, responsible for developing and executing global labeling strategies for innovative medicines. Main objectives include leading target labeling development, aligning labeling content with global regulatory requirements, and collaborating cross-functionally with clinical, safety, market access, and medical teams to ensure regulatory compliance and strategic alignment. Responsibilities encompass managing labeling content for multiple markets, guiding health authority discussions, overseeing labeling documents (CCDS, USPI, EUPI), and leading labeling working groups and governance reviews. The role involves providing scientific and regulatory guidance, driving process improvements, and supporting inspections and audits. Qualifications: Bachelor’s in a scientific discipline (advanced degrees preferred), 8+ years of professional experience, with at least 6 years specifically in regulatory labeling for pharmaceuticals, including target labeling and NME submissions. Industry experience in Regulatory Affairs, Clinical, Medical Information, or Pharmacovigilance is required, with a strong understanding of worldwide regulatory guidelines and drug development processes. Skills needed include project leadership, scientific communication, document management, and cross-functional collaboration. High-value specifics include focus on pharmaceutical products, global regulatory compliance, and experience with complex labeling projects. The role is hybrid, based in Raritan, NJ; Titusville, NJ; or Horsham, PA, with potential external collaboration.