Regulatory Affairs

Students in Regulatory Affairs programs learn about food and drug law, product life cycles, clinical trials, post market issues, technical writing and risk management. This knowledge prepares students for work in industries that must comply with extensive government regulations such as pharmaceutical and biotech companies, medical device manufacturers, and some food industries.  Regulatory affairs professionals work with federal (FDA or EMA), state, and local regulatory agencies and personnel to ensure the appropriate regulations are being followed.

Courses may include:

• Safety and Regulatory Compliance
• Food and Drug Laws
• Clinical Trials
• Risk Management for Drugs and Medical Devices
• Product Life Cycle