Senior Director, Regulatory Transformation & Innovation

Senior Director, Regulatory Transformation & Innovation Job Summary The Senior Director, Regulatory Transformation & Innovation is a strategic leadership role within Regulatory Operations responsible for driving the implementation of transformation initiatives across Global Regulatory Affairs (GRA). This Senior Director will define and execute a transformation and innovation strategy that modernizes GRA-related processes by enabling new ways of working through application of digitization, AI/ML, analytics, automation, and technology solutions. Working across GRA and cross-functional partners, the Senior Director will identify, prioritize, and implement opportunities to enhance organizational effectiveness and drive business value, including through innovative approaches to regulatory document development, knowledge management, data utilization, and decision support. The role will ensure innovation efforts are grounded in GRA business needs, aligned to regulatory requirements and enterprise priorities, and focused on measurable business outcomes. The ideal candidate will bring deep expertise in Regulatory Affairs, along with a proven track record of leading transformation, innovation, analytics, AI, or digital enablement initiatives in regulated environments. The successful candidate will serve as a trusted advisor to senior leadership, fostering a culture of innovation, continuous learning, and transformation across GRA. This is a hybrid role requiring a minimum of three days per week onsite at our Boston (Seaport) location.

Develop and execute a Regulatory Transformation & Innovation strategy aligned with GRA objectives and enterprise priorities, while ensuring delivery of practical business outcomes. Lead strategy, design, digitization, implementation, and continuous improvement of end-to-end global regulatory affairs practices to drive value, including increased efficiencies and reduction of manual work effort (e.g., end-to-end regulatory document authoring, workflow automation, structured content development). Identify, prioritize, and advance emerging opportunities to enhance regulatory capabilities through innovation, AI, analytics, automation, and evolving industry practices (e.g., cloud-based regulatory submissions). Continuously assess external trends, regulatory innovation, and industry best practices to inform strategic priorities and capability investments. Lead innovative approaches to regulatory content development, knowledge management, data utilization, and decision support (e.g., structured content development). Partner with stakeholders to identify and implement advanced technology capabilities, which improve quality, accelerate delivery, and enhance organizational effectiveness. Establish governance, prioritization, and value-realization frameworks to evaluate and advance transformational opportunities across GRA. Collaborate across functions to align transformation initiatives with business priorities, organizational goals, and regulatory requirements. Build strong relationships with external partners, industry groups, and vendors to bring innovative ideas and capabilities into the organization. Serve as a strategic advisor to senior leaders on innovation opportunities, transformation priorities, and organizational readiness. Communicate progress, impact, and lessons learned across the organization to maintain transparency, momentum, and alignment. Define, monitor, and communicate measurable improvements in organizational effectiveness, business performance, quality, agility, and user experience.

Bachelor’s degree required; advanced degree preferred. 10+ years of experience in Regulatory Affairs, life sciences, or other regulated industries, with a strong understanding of regulatory processes, regulatory content development, submissions management, or comparable regulated business functions. 10+ years of experience leading