Certificate in Regulatory-Legal Affairs in Biotechnology

This 12-semester hour certificate program prepares the student for supervisory, administrative, or other leadership positions within the Biotechnology industry. Courses within this program will explore market dynamics, public policy, and technology. The student will learn the basics of tech transfer policies and IPOs, communicating scientific concepts to investors, and preparing regulatory plans. Some course activities will prepare the student to create and analyze legal documents, including tech transfer, product validation, and responding to recall procedures. The curriculum also provides an overview of key legal concepts and policies that govern the biotechnology industry’s research, development, and commercial activities. Upon completing this certificate program, the student will have creative problem-solving skills and other competencies necessary for standard approaches in managing biotech research and development as per regulatory guidelines and federal compliance protocols. The GRAD 695 course allows the participant to customize the research proposal for their area of interest within the regulatory-legal affairs area in the biotechnology industry. A student may complete this certificate program as a non-degree graduate student or a Master of Science degree-seeking student.