Regulatory Affairs

The San Francisco Bay Area's Only Comprehensive Regulatory Affairs Certificate Program

Regulatory affairs professionals play critical roles in ensuring compliance with the laws and regulations guiding the development and commercialization of health care products. As Bay Area bioscience companies grow and mature, their need for trained regulatory personnel intensifies. Recent industry studies cite regulatory affairs as one of the most crucial human resource needs in the coming decade. And UCSC Extension in Silicon Valley offers the Bay Area's only comprehensive classroom-based certificate program in this key field.

Expert Instructors Bring the Regulations to Life

UCSC Extension’s Regulatory Affairs Certificate Program was developed with the guidance of industry and government experts. It provides broad regulatory foundations, exposure to the practical, real-world applications of the regulations. The program also builds appreciation of the important roles that regulatory affairs professionals play in the bioscience industry. Courses are taught by experienced regulatory professionals currently working in the device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse courses with relevant examples and hands-on exercises designed to prepare students for careers in regulatory affairs.

Benefits of Completing Our Regulatory Affairs Certificate

This highly-interactive program provides:

• In-depth coverage of U.S. and international laws and regulations governing testing, manufacture and distribution of medical devices, diagnostics, pharmaceuticals, and biologics
• An understanding of the complex processes central to developing and bringing new medical products to market
• Hands-on experience with the documentation required for new product approval and for product surveillance
• Grounding in the ethical,management and professional competencies needed to be effective in regulatory roles
• Strategic thinking and analytical skills applicable to regulatory functions in the biomedical industry

Who Should Attend This Program

Regulatory personnel come from a variety of backgrounds, including clinical, engineering, law, manufacturing, QA/QC, research, and medical and allied professions. The Regulatory Affairs Certificate is designed to build on these foundations and overlay the regulatory principles, practices and strategies needed by professionals entering the field of regulatory affairs. It also increases the knowledge and competency of those already working in regulatory affairs, especially in entry-level or mid-level positions.