Director, Regulatory Data Office Leader

Role: Lead the Regulatory Data Office within Global Regulatory Affairs, focusing on data stewardship, governance, and integrity to support regulatory submissions and decision-making. Responsibilities: oversee the Regulatory Data Hub, establish governance policies, chair the Regulatory Data Council, and ensure data quality, standards, and compliance with global regulations (e.g., IDMP, SPOR). Drive data-driven transformation initiatives, support RIM projects, and embed data governance into enterprise-wide digital solutions, including AI and automation. Lead and develop a global team of data stewards, fostering collaboration across R&D, IT, and Data Science. Qualifications: Bachelor’s in Science, Business, or related; 10+ years in pharma/healthcare, with at least 2 years managing teams; deep regulatory domain expertise; experience with data standards (Veeva Vault RIM, IDMP), data governance, and regulated data environments. Preferred skills include knowledge of regulatory systems, digital transformation, and AI tools, along with strong leadership and cross-functional influence capabilities. HighValue: global regulatory data governance, compliance with IDMP/SPOR, RIM platform expertise, cross-functional leadership, digital transformation, and regulated data management. WorkSetup: hybrid in Horsham PA, Raritan NJ, or Titusville NJ.