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. Objectives include aligning labeling content with regulatory requirements, competitive landscape, and therapeutic area insights, and leading cross-functional collaborations for target labeling development. Responsibilities encompass leading target and primary labeling creation, providing strategic guidance for local market labeling, managing health authority discussions, and ensuring compliance and scientific integrity of labeling documents. The role involves representing global labeling in regulatory teams, leading strategic discussions, and supporting inspections. Qualifications: Bachelor’s in a scientific discipline (advanced degrees preferred), with at least 8 years of professional experience and 6 years in regulatory labeling content development, ideally with NME experience. Industry background in regulatory affairs, clinical, medical, or pharmacovigilance, and familiarity with worldwide labeling guidelines is required. Skills include project leadership in matrix environments, scientific communication, document management systems proficiency, and strong organizational abilities. High-Value: Focus on innovative medicines, regulatory labeling for pharmaceuticals, involvement in global regulatory strategies, and cross-functional stakeholder engagement. Location: Hybrid roles available in NJ and PA; travel requirements not specified.