Regulatory affairs is the profession responsible for ensuring that pharmaceutical, biotechnology and medical device products meet regulatory requirements throughout development, approval and commercialization. Regulatory affairs professionals work with health authorities such as the FDA and international regulatory agencies to help bring safe and effective products to market.
No prior experience is required to begin the program, although a bachelor's degree is recommended. The curriculum is designed to provide foundational and advanced knowledge for individuals who are new to regulatory affairs as well as for professionals seeking to deepen their expertise.
The Professional Program in Regulatory Affairs is designed for professionals seeking to enter or advance in regulatory affairs, quality, compliance, clinical research, pharmaceutical development, biotechnology, medical devices and related life sciences fields. It is also appropriate for individuals looking to expand their understanding of regulatory requirements across the product development lifecycle.
This program prepares students for a variety of roles within the life sciences industry, including regulatory affairs associate, regulatory affairs specialist, regulatory operations associate, clinical regulatory associate and other positions supporting regulatory strategy, submissions and compliance. Graduates may also find opportunities in related functions such as quality assurance, quality systems and product development within pharmaceutical, biotechnology and medical device organizations.
Yes. Many regulatory affairs professionals begin their careers in scientific, clinical, quality, manufacturing, engineering or health care-related roles. This program helps students build the regulatory knowledge and industry perspective needed to support a transition into regulatory affairs.
Yes. Many students complete the program while working full time. Courses are scheduled during evenings and weekends to support working professionals balancing career, family and educational goals.
Students gain knowledge and practical skills in FDA regulations, global regulatory requirements, Good Practice (GxP) principles, regulatory submissions, clinical trial applications, product approvals, commercialization, quality systems, compliance and regulatory strategy.
No application is required. Students may register for the program at any time. A one-time, nonrefundable registration fee is required to declare your intention to complete the curriculum and earn the Award of Completion.
Students have up to three years to complete the program requirements. Most students complete the program within one to two years, depending on their course load and schedule.
Students are strongly encouraged to begin with Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices. This course provides a foundation in regulatory affairs concepts, terminology and industry practices that support success in subsequent coursework.
Courses are offered during the spring, summer and fall terms. Required courses are offered regularly throughout the academic year. Please visit the program website or contact biotech_online@berkeley.edu to inquire about specific courses.
The program provides foundational knowledge in FDA regulations, global regulatory requirements, GxP principles, regulatory submissions and compliance that can support preparation for professional credentials offered by the Regulatory Affairs Professionals Society (RAPS), including the RAC. Students should review certification eligibility requirements directly with RAPS.
Students learn from instructors who are experienced industry professionals and they engage with classmates from a variety of professional backgrounds. These interactions provide opportunities to build professional connections and gain insight into current industry practices.
While our students are not eligible for federal financial aid programs related to FAFSA, students may consider private education loans. More information about financial assistance options is on the website.
While the program does not provide formal internship or job placement services, students regularly receive information about relevant internships, job openings and industry events. The program's industry-focused curriculum and networking opportunities can help students strengthen their qualifications and expand their professional connections.
If you have any additional questions or would like guidance on whether the Professional Program in Regulatory Affairs is right for you, please contact biotech_online@berkeley.edu. You may also attend an online information session to learn more about the curriculum, course offerings and career pathways and allow you to ask staff questions in real time.