Graduate Certificate in Biotechnology Regulatory Science

Northeastern University

The Graduate Certificate in Biotechnology Regulatory Science is designed in response to a need in the biotechnology industry for individuals, in particular regulators, to obtain a strong foundation in the science behind good regulatory practice today, specifically in relation to biopharmaceuticals.Regulatory convergence, or aligning drug approvals globally, is one of the most important things for patient safety and ensuring that effective drugs are delivered to patients in a timely manner. An integral part of regulatory convergence is ensuring that regulators understand the science behind the regulatory policies. This program will prepare individuals to understand both the technical aspects of the science as well as the policies. In addition, students have access to the same courses that international regulators are taking.The multi-billion-dollar biotechnology industry is diverse, growing, and filled with opportunity. Individuals with advanced scientific knowledge, intellectual flexibility, drive, and professional skills can pursue paths of innovation with the potential to meet critical healthcare and environmental challenges-and to change lives. The industry’s unparalleled growth is projected to continue in the coming years. The result is an ongoing expansion of career opportunities on every level and in every industry sector, from large pharmaceutical operations to entrepreneurial biotechnology start-ups.