Sr. Director, Regulatory Affairs, Technology & Transformation

Position Summary

The Sr. Director, Regulatory Affairs, Technology & Transformation is a strategic role within Regulatory Operations responsible for defining and executing the technology, data, training, and transformation agenda for Global Regulatory Affairs. The role modernizes regulatory processes and capabilities through fit-for-purpose platforms, digitization, automation, analytics, artificial intelligence, structured content, and innovative ways of working. This leader connects business strategy with operational execution, ensuring solutions are compliant, scalable, adopted by users, and focused on measurable improvements in quality, speed, transparency, and organizational effectiveness.

Primary Responsibilities

• Develop and execute Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs objectives, corporate pillars, portfolio needs, and regulatory requirements
• Establish governance, prioritization, investment, and value-realization frameworks for technology and transformation initiatives, with clear roadmaps, ownership, dependencies, risks, and success measures
• Serve as a trusted advisor to Regulatory and senior enterprise leaders on capability priorities, emerging technologies, organizational readiness, and sustainable operating-model change
• Identify, evaluate, prioritize, and responsibly implement opportunities involving AI, advanced analytics, automation, digital authoring, structured content, and decision-support capabilities
• Provide business leadership for the effective deployment, advancement, integration, validation, maintenance, training and adoption of regulatory information and document management capabilities, including RIM, DMS, publishing, submission, archiving, commitment tracking, and reporting solutions
• Partner with IT, Quality, Regulatory Operations, and business stakeholders to define user requirements, select and implement systems, manage upgrades and change controls, and maintain compliant, inspection-ready solutions
• Advance interoperable regulatory data and content capabilities, including structured content, knowledge management, analytics, workflow automation, cloud-enabled submissions, APIs and connectors, and responsible AI/ML use cases
• Ensure regulatory platforms interface effectively with other relevant GxP and enterprise systems to enable secure, efficient information exchange across Clinical, Quality, Technical Operations, Commercial, Program Management, and related functions
• Lead the design, digitization, implementation, and continuous improvement of end-to-end regulatory processes, reducing manual effort, cycle time, rework, and operational risk while improving predictability and user experience
• Oversee relevant policies, SOPs, work instructions, standards, job aids, training, and governance practices that support consistent, compliant execution across regions and programs
• Use metrics, analytics, assessments, and user feedback to identify improvement opportunities and demonstrate measurable business outcomes
• Lead organizational change management, stakeholder engagement, communications, training, and adoption strategies that embed new capabilities and ways of working
• Foster a culture of innovation, continuous learning, disciplined experimentation, and accountability while ensuring innovation remains grounded in business needs and compliance expectations
• Monitor external regulatory technology trends, evolving health authority expectations, industry practices, and peer networks to inform capability investments and strategic direction
• Communicate progress, benefits, risks, decisions, and lessons learned clearly to technical, operational, and executive audiences
• Other responsibilities as assigned

Education/Experience/Skills

• Bachelor’s degree in life sciences, information systems, business, engineering, or a related field; advanced degree preferred. An equivalent combination of relevant education and experience may be considered
• Targeting 12 years of progressive experience in Regulatory Affairs, Regulatory Operations, regulatory technology, or a comparable regulated life sciences function, including significant leadership responsibility
• Demonstrated success developing and executing regulatory technology, digital enablement, analytics, or enterprise transformation strategies that deliver measurable business outcomes
• Deep understanding of global regulatory processes, regulatory content development, submission management, eCTD standards, document and records management, archiving, health authority interactions, and inspection-readiness expectations
• Strong experience with Regulatory Information Management and Document Management platforms; experience with Veeva RIM, IQVIA SmartSolve, Lorenz Docubridge or comparable enterprise regulatory platforms is highly valued
• Proven strategic and enterprise-minded with the ability to connect long-term regulatory capability strategy with practical execution and near-term business priorities
• Experience leading regulated system implementations, integrations, upgrades, validation, change control, business process design, governance, and lifecycle management in partnership with IT and Quality
• Active engagement in regulatory operations, technology, and industry forums, with a strong external network and awareness of emerging practices
• Demonstrated experience with organizational change management, stakeholder engagement, training, and adoption of new systems and processes across global, cross-functional organizations, and ability to lead complex change with disciplined governance, clear outcomes, and sustained adoption
• Proven people leadership, including developing teams and managing employees, contractors, consultancies, and distributed or remote resources
• Exceptional communication, influence, judgment, and executive presence, with the ability to translate complex business and technical issues into clear decisions and practical action
• Collaborative and influential to build alignment across Regulatory, IT, Quality, and business functions without relying solely on formal authority
• Experience leading AI, machine learning, advanced analytics, knowledge management, workflow automation, structured content, or cloud-enabled regulatory submission initiatives
• Surfaces risks early, makes sound decisions, and follows through on commitments
• Balances innovation and speed with regulatory, GxP, security, privacy, and inspection-readiness expectations
• Willingness and ability to travel domestically and internationally as needed