Regulatory Affairs

Certificate Program

The California State University, East Bay Advanced Certificate in Regulatory Affairs is designed for professionals who serve or seek to serve in a regulatory affairs role in the pharmaceutical, biopharmaceutical, or medical device industries.

Those who take advantage of the program will acquire a thorough knowledge of the laws and regulations mandated by the federal government, especially those of the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, commercialization, and postmarking surveillance of pharmaceutical, biopharmaceutical, and medical device products. Offered in collaboration with San Diego State University's Center for Bio/Pharmaceutical and Biodevice Development, the program's online-only format makes it convenient for busy professionals anywhere in the world, not just those who live or work in the San Francisco East Bay Area.

Program Objectives

• To give graduates a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical, and medical device products.
• To prepare graduates for regulatory affairs positions in the pharmaceutical, biopharmaceutical, and medical device industries.
• To equip graduates with the educational foundation that will help them advance in the regulatory affairs profession.

Who Should Attend

• Individuals interested in pursuing a career in regulatory affairs who seek a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products.
• Individuals seeking to advance in the regulatory affairs profession.
• Professionals currently working in pharmaceutical, biopharmaceutical, or medical device companies who seek a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products.

Program Highlights