Regeneron is seeking a Director, ICSR Knowledge & Process Optimization to join our organization.

In this role, a typical day might include:

The Director of ICSR Knowledge & Process Optimization is accountable for developing, maintaining, and continuously improving global procedures, standards, and tools that enable high-quality, compliant, and efficient individual case safety report (ICSR) processing and adverse event reporting across both developmental and marketed products. This role ensures end-to-end ICSR process robustness—from intake through expedited submissions and periodic reporting—by driving harmonized procedures, risk-based quality controls, and technology-enabled automation. The Director partners closely with GPS Standards and Training, Signal Management, Safety Sciences, Clinical Development, Quality/QA, Regulatory, Medical Information, IT, and Commercial to ensure timely compliance with global regulations while advancing operational excellence.