Director, Regulatory Data Office Leader

Overview Lead a global Regulatory Data Office to ensure trusted regulatory data supports analytics, decision-making, and end-to-end regulatory information management. You will drive data governance, quality, and stewardship across the Regulatory Data Hub and related platforms, partnering with R D, IT, and enterprise functions to enable transformation. This role offers impact across GRA programs, helping to embed governance into major initiatives like URP, iLabeling, and AI-enabled tools. You will shape a world-class data-enabled regulatory operations organization. Verantwortungsbereiche Advocate for regulatory data integrity and establish accountability for data ownership and quality across systems Lead the Regulatory Data Council and harmonize with enterprise data governance frameworks Own day-to-day governance of the Regulatory Data Hub and align data domains with data products Guide end-to-end RIM transformation through URP and support submission-excellence initiatives with governed data Lead and develop a global team of data stewards, setting priorities and performance expectations Collaborate across R advanced degree preferred 10+ years in a medium-to-large-scale pharmaceutical/MedTech environment 2+ years people management experience Experience as data steward or governance lead for data standards, quality, metadata Strong data analysis skills and ability to translate data into actionable strategies Understanding of data standards, data architecture/tools, and governance in regulated contexts Knowledge of quality management and compliance in drug development Proven ability to influence in a global, matrix organization and build cross-functional trust Excellent verbal and written communication, negotiation, and relationship-building skills Leadership Collaborative mindset Influence without authority Data governance and stewardship Regulatory data standards (IDMP, SPOR, xEVMPD) Regulatory Information Management (RIM)