You will be responsible for:
· Lead the Global Regulatory Affairs organization and establish regulatory strategy aligned with corporate and portfolio objectives.
· Provide strategic regulatory leadership across all stages of development, from early research through commercialization and lifecycle management.
· Oversee global regulatory submissions, approvals, labeling strategies, maintenance activities, and regulatory compliance.
· Serve as the primary regulatory representative with FDA, EMA, PMDA, and other global health authorities, leading critical agency interactions and negotiations.
· Ensure regulatory risks, opportunities, and strategies are effectively integrated into portfolio, investment, and development decisions.
· Partner with R&D, Medical, Commercial, Quality, Manufacturing, and Executive Leadership teams to drive successful global development and registration outcomes.
· Build, develop, and retain a high-performing global regulatory organization while ensuring effective resource allocation and succession planning.
· Lead the digital and AI transformation of Global Regulatory Affairs, including regulatory information management, automation, data governance, advanced analytics, and AI-enabled regulatory intelligence and submission capabilities.
· Partner with Digital, IT, Data Science, Quality, Compliance, and business leaders to ensure responsible adoption of digital tools and AI, with appropriate standards for data quality, privacy, transparency, validation, inspection readiness, and regulatory compliance.
· Represent the company externally through regulatory agencies, industry associations, and key scientific and policy forums.