Description
The Global CMC Regulatory Affairs Manager will lead a team of global CMC RA managers and serve as the global regulatory expert for Chemistry, Manufacturing & Controls activities supporting Cell & Gene Therapy products. The role oversees regulatory strategy across development, registration, and lifecycle management; reviews and approves CMC sections in regulatory submissions; guides manufacturing, analytical, validation, and control strategies; assesses regulatory impacts of manufacturing changes; supports interactions with global health authorities; and drives regulatory risk assessments. The position requires a master's degree or PhD in a relevant scientific discipline, at least 12 years of CMC regulatory experience for Cell & Gene Therapy products, and extensive biotechnology or pharmaceutical regulatory affairs experience. Compensation is $249,995–$272,020 per year, with health, vision, dental insurance, and a 401(k) plan.
