Northeastern’s graduate programs in biotechnology experienced remarkable growth in the first decade of the 21st century. A key part of this growth was the launch, with support from the Sloan Foundation, of Professional Science Master’s (PSM) programs in bioinformatics, biotechnology, and, in 2010, biopharmaceutical regulatory science.

Regulatory science encompasses the scientific and technological basis for production, regulatory approval, and subsequent monitoring of biopharmaceutical substances. The discipline is different from regulatory affairs, which is concerned with the development and enforcement of regulations through clearly defined administrative protocols. It is also distinctive from the research and development that supports drug discovery and development.

Students study protein and carbohydrate chemistry, bioprocess engineering, immunology and immunogenicity, and analysis and characterization methodologies in both classroom and laboratory settings. These technical courses are augmented with business courses in regulatory issues, business, communications, and how to succeed in a regulated workplace. Students acquire the core competencies necessary to prepare them for highly valued positions in the biotech and pharmaceutical industries and in government agencies such as the FDA.