Manager, Regulatory Affairs – Global Labeling, PDx

Job Description Summary The Manager, Regulatory Affairs – Global Labeling is responsible for developing and executing global labeling strategies for assigned PDx products, with primary accountability for US FDA labeling activities and US Prescribing Information. The role partners with Clinical, CMC, Safety, Medical, Commercial, global Regulatory Affairs and regional Regulatory Affairs teams to ensure labeling is scientifically sound, globally aligned, and supports product development, registration, lifecycle management, and commercialization. Job Description Key Responsibilities G lobal Labeling Strategy Lead global labeling strategy for assigned products, with primary focus on US FDA requirements and labeling expectations.…