Senior Director, Regulatory Transformation & Innovation

Role: Senior Director, Regulatory Transformation & Innovation, leading strategic initiatives to modernize Global Regulatory Affairs through digitization, AI/ML, automation, and analytics. Responsibilities: develop and execute transformation strategies aligned with GRA goals, drive process efficiencies (e.g., regulatory content development, workflow automation), and implement innovative technology solutions to enhance regulatory capabilities. Collaborate cross-functionally with internal partners and external vendors, establishing governance frameworks and guiding organizational change. Serve as a senior advisor on innovation and transformation, communicating progress and measuring impact on organizational effectiveness and business outcomes. Requirements: Bachelor's degree (advanced degree preferred); 10+ years in Regulatory Affairs or regulated industries, with extensive experience leading digital and strategic transformation initiatives; proven expertise in AI, analytics, knowledge management, and change management within regulated environments. HighValue: focus on regulatory content, data utilization, and technology enablement in life sciences; hybrid work setup in Boston (Seaport); no specific therapeutic areas or modalities specified but applicable to broad regulatory functions in biopharma.