Director, Regulatory Data Office Leader

Role: Lead the global Regulatory Data Office within Johnson & Johnson's Regulatory Affairs, focusing on data stewardship, governance, and quality for innovative medicine development. Objectives: Establish trusted, high-quality regulatory data to enhance analytics, decision-making, and regulatory transformation. Responsibilities: oversee regulatory data governance policies, manage the Regulatory Data Hub, chair the Regulatory Data Council, and drive end-to-end data integrity across R&D and enterprise platforms like URP, MDM, and eLabeling. Collaborate with R&D, IT, Data Science, and cross-sector teams to embed data standards, support global initiatives, and enable regulatory process transformation. Lead a global team of data stewards, define data standards, and ensure compliance with global health authority requirements. Qualifications: Bachelor’s in Science, Business, or related field; 10+ years in pharma/healthcare, with at least 2 years in data governance or stewardship roles, and prior people management experience. Preferred: experience with regulatory systems (e.g., Veeva Vault RIM, IDMP, SPOR), digital transformation, and AI tooling in regulated environments. High-Value: focus on regulatory data standards, compliance (IDMP, xEVMPD), governance in R&D, clinical, safety, and supply chain contexts, supporting global regulatory submissions and transformation initiatives. Location: Hybrid roles in PA or NJ; travel not specified.