Regulatory Affairs



Regulate the Positive

How do bioscience professionals ensure that new products are safe and effective?

Before a new medical device, drug, biologic or diagnostic is introduced to the public, it must meet minimum regulatory requirements. Regulatory affairs professionals ensure compliance with the laws and regulations guiding the development and commercialization of healthcare products. Our Regulatory Affairs certificate will familiarize you with the fundamentals of drug development, new product documentation, and ethical and management competencies needed to succeed in this field.

Pick up skills course by course or declare candidacy for the certificate to add a UC credential to your resume.

FDA: What You Need to Know

Unsure how to respond to FDA audits and requirements? Our courses detail the legal processes and procedures regulatory personnel need to know to help get a drug to market.

Global Outlook

Regulations vary from country to country. Our curriculum offers practical insight on navigating regulations in the US and around the world.

Prepare for the RAC

Working toward Regulatory Affairs Certification? Prepare for this rigorous exam by immersing yourself in the certificate.

Earn Two Certificates For Less

Complete two Bioscience certificates, simultaneously or in sequence, with fewer units, by selecting shared electives. Contact us to get help creating a personalized study plan.


"The coursework was fantastic; it helped me prepare for the RAC exam." –Leena Kadakia

The Profession

Quality + Compliance = Success

Skilled regulatory affairs professionals are needed in a variety of settings, including:

  • Small, mid-size and multinational companies
  • Government agencies such as the US FDA or the European Medicines Agency
  • Clinics and hospitals
  • Universities invested in research and clinical trials
  • Consultancies
  • Clinical research operations (CROs)

While the scientific and regulatory background is critical, regardless of your position, as your career progresses it will be even more important to ensure that your knowledge of regulations is up-to-date—and that you are able to communicate changes clearly and effectively.


  • Average Earnings

In 2016, the Regulatory Affairs Professional Society surveyed 3,358 regulatory professionals around the world to inquire about compensation and experience. Among the findings, respondents reported an average increase of 5.9% in base compensation from 2014-15 levels. –2016 Scope of Practice & Compensation Report for the Regulatory Profession


“The program further enhanced the knowledge and skillset that I gained through on-the-job training as a regulatory affairs professional.” –April Raj


Program Objectives

As a graduate of the Regulatory Affairs certificate program, you’ll have the skills to:

  • Provide regulatory submissions of drugs and biologics
  • Differentiate the roles and responsibilities between quality assurance (QA) and quality control (QC)
  • Understand and apply GXPS (Good Manufacturing Practices (GMPS)/Quality System Regulation) for drugs/biologics/medical devices.
  • Apply risk management principles to products, processes and services within biomedical industries
  • Set up and implement medical device verification and validation programs


"The program definitely opened the door for me." –Shilpa Mydur


Program Format

UCSC Extension’s Regulatory Affairs courses are offered at UC Santa Cruz Silicon Valley Campus, a beautiful facility located on the corner of Scott and Bowers in Santa Clara. Many of our courses are available online. Choose courses according to your interest or declare candidacy in the certificate for a more comprehensive overview of the field.

Regulatory Affairs Courses

Total: 19 units

Required: 6 courses

Electives: 5 units required

To complete the certificate, you must complete a minimum of 19 units; 6 required courses and at least 5 units of elective courses.

Required Courses:

All of the following:

  • Regulation of Drugs and Biologics, 3 units
  • Regulation of Medical Devices and Diagnostics, 3 units
  • Interacting with the FDA, 1.5 units

One of the following:

  • Drug Development Process, 3 units  OR
  • Design Control for Medical Devices, 2 units

One of the following:

  • Regulatory Submissions: Drugs and Biologics, 2 units  OR
  • Regulatory Submissions: Devices and Diagnostics, 2.5 units

One of the following:

  • Good Manufacturing Practices, 3 units  OR
  • Quality Systems for Medical Devices FDA QSR and ISO 13485, 2.5 units


5 units required

  • Design Control for Medical Devices, 2 units
  • Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics, 1.5 units
  • Global Medical Device Submissions and Strategy, 1.5 units
  • Good Clinical Practices, 3 units
  • Medical Device Marketing, 3 units
  • Mobile Health: The Evolving Industry and Regulatory Landscape, 1 unit
  • Post-Market Regulatory Obligations for Medical Devices, 1.5 units
  • Preparing for FDA Inspections and Conducting Sponsor Audits, 1.5 units
  • Regulation of in vitro Diagnostics in Europe and the U.S., 2.5 units
  • Risk Management for Regulated Industries, 3 units
  • Validating Software for Medical Devices and Emerging Technologies, 2 units
  • Value-Added Quality Audits, 1.5 units

Also Recommended

  • Data Privacy and Security for Healthcare and Biosciences, 1.5 units

Also of Interest

  • Clinical Trials Essentials: An Intensive One-Week Course, 3.5 CEUs


Given the scientific foundations of the bioscience industry and the importance of effective communication to the regulatory role, students who come to the program with a basic understanding of the life sciences and strong written and oral communication skills will gain the most from this program.

Recommended Course Sequence

We recommend students begin the program with “Quality Systems for Medical Devices FDA QSR and ISO 13485" (formerly titled "Medical Device Quality Systems”) or “Good Manufacturing Practices,” followed by “Drug Development Process” or “Regulation of Medical Devices and Diagnostics.”

Any one course from UCSC Extension's Clinical Trials Design and Management or Medical Devices Certificate Programs may be applied toward the elective unit requirement for the Regulatory Affairs Certificate.


Want to learn more about our curriculum in person? Join us for a free Info Session to learn more about our courses, faculty, and program requirements. Learn more on our Events page.


The rough cost of the Regulatory Affairs certificate is estimated at $8,000.



No application is required to enroll in our courses or certificate programs. Information about our open enrollment process can be found on our Enrollment page. If you have any questions about our programs, please contact the UCSC Extension Outreach office by phone at 408-861-3860, or by email at

From the schedule below, click on a course title to see sections available for enrollment. You may view the full course schedule, or enroll in the course, by clicking the respective button. The course type offerings (classroom, online, blended) are guidelines and subject to change. A blended (hybrid) course has both classroom and online components.

Declaring Candidacy

If you intend to pursue a certificate, declaring candidacy establishes program requirements early in your studies, so any subsequent curriculum changes do not affect your progress. It does not limit what courses you can take; and it helps you structure your professional development program for maximum benefit to you. Go the declare candidacy page to establish your requirements for this program. Certificate program requirements must be completed within three years of declaring candidacy.

Course Schedule

1. Total of Six Required Courses.
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X403 Regulation of Drugs and Biologics 3.0 Classroom Classroom
REGL.X404 Regulation of Medical Devices and Diagnostics 3.0 Classroom Classroom
REGL.X402 Interacting with the FDA 1.5 Classroom
2. Required Course (A) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
BTEC.X401 Drug Development Process 3.0 Classroom Classroom Classroom
MEDD.X400 Design Control for Medical Devices 2.0 Blended Blended
3. Required Course (B) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X405 Regulatory Submissions: Devices and Diagnostics 2.5 Classroom
REGL.X406 Regulatory Submissions: Drugs and Biologics 2.0 Classroom
4. Required Course (C) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X400 Good Manufacturing Practices 3.0 Classroom Classroom
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485 2.5 Classroom Classroom
5. Elective Courses
6. Also of Interest
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
CTDM.X407 Data Privacy and Security for Healthcare and Biosciences 1.5
CTDM.X801 Clinical Trials Essentials: An Intensive One-Week Course 3.5 Classroom
7: Required Certificate Review
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
O-CE0364 Regulatory Affairs Certificate Completion Review Online Online Online Online


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Department: Business and Management


During her years as an arts administrator for the San Francisco Museum of Modern Art, Elisa Ordona learned a thing or two about finance and development. Though she believed in the arts, Ordona discovered that her passion for finance was on the...

Department: Business and Management
olga nieves


Olga Nieves wanted to find a way to refresh her business skills while preserving her humanitarian approach to staff development and training. She enrolled in UCSC Extension’s ...

Department: Business and Management


Bhavna Dixit worked as a biotechnology research scholar in India before moving to California in 2015. Armed with a master’s degree in biotechnology and work experience abroad, she started researching programs that could prepare her to work in the Bay Area....

Department: Biosciences
niki theil


Niki Theil had worked in corporate finance for eight years before quitting to raise her children. While her children were young, Theil focused her mathematical talents on fine-tuning their household spending, an exercise that proved useful, not...

Department: Business and Management


When Shyla Jain started looking for professional certification programs in the Bay Area, she had a big goal in mind: to gain the skills and experience she’d need to land her first job in Silicon Valley. Before she moved from India to the United States, she...

Department: Business and Management


As an educator with 20 years of experience as a teacher, tutor and coach, Patrice McElligott advocates for her students’ needs, regardless of the environment. After obtaining her Clear Multiple Subject and Special Education credentials, she completed a...

Department: Education
isabel barrios


Isabel Barrios is accustomed to standing out in her field. As the only woman in her graduate electrical engineering program at the University of Guadalajara, she discovered her passion for technology at an early age. She left Mexico to pursue...

Department: Business and Management


When Tatiana Boytsova completed her degree in linguistics and philology in Russia, she ignited a passion for learning, language acquisition, and teaching. She explored her love for English while living in Australia, and by the time she moved to California...

Department: Education
priya raman


By the end of her one-day “Human Resource Management, Introduction” course, Priya Raman had decided that she wanted to be a corporate trainer. Though she had worked in HR in India before relocating to California, Raman wanted to gain a strong...

Department: Business and Management


When Nabeha Khan moved to the U.S. from Pakistan, she had already completed a master’s in business administration and was busy raising young children. Hungry for work opportunities in Silicon Valley, she discovered UCSC Extension’s Human Resource Management...

Department: Business and Management
dana torres


When Dana Torres started taking Environmental Health and Safety courses at UCSC Extension, she was surprised and excited to learn skills that she could take back to work the very next day.

“Whenever I took a class, something...

Department: EHS


When Mark Chang first noticed UCSC Extension’s brochure for Database and Data Analytics, he said it was “love at first sight.” He had recently completed his master’s in finance and was looking for a way to stand out in a competitive field. He...

Department: Engineering


Angela Alcantara-Cruz is an early childhood educator with a unique backstory. After graduating from UCSC with a degree in sociology, she earned a master’s in organizational development and led a successful 20-year career in business operations in the...

Department: Education


When Shelley Odell graduated from college, she realized that she had developed a strong scientific foundation, but like many recent grads, she wasn’t sure how to apply this knowledge to her job. Shortly after landing her first position, her...

Department: EHS


Meghna Patel worked as a human resources professional for a Canadian company for many years before deciding it was time for a shift in career. Though she had been trained as an engineer, after 10 years in recruitment she had not had the opportunity to...

Department: Engineering


When Poc Hsu enrolled in UCSC Extension’s Computer Programming certificate program, he didn’t realize that he would soon be applying his programming skills to benefit his fellow students. While he was planning his course schedule, he developed an application...

Department: Engineering
ravi kalluri



RAVI KALLURI, M.S.E.E. from Stanford, M.B.A., PMP® and Certified Scrum Master, has more than 15 years of experience leading complex software development projects. He has four years of experience teaching project management.

Department: Business and Management


Between her undergraduate, graduate degree and now her professional certificates, Sudha Shankar has pursued her education in three different continents. She graduated with a bachelor’s in electrical and electronics engineering at a premier institution in...

Department: Business and Management, Engineering


Matthew Laws had been working in environmental compliance at a company in Northern California for five years when he decided to enroll in the Environmental Health and Safety (EHS) program in early 2011.

“I was looking in my murky crystal ball,...

Department: Biosciences


When Manya Jain moved from India to California with her husband, she had already worked as a financial data analyst with a few projects in process optimization for six years. Her daughter was only six months old, so she decided to research creative ways to...

Department: Business and Management, Engineering


Eduardo Lozada came to the United States from Bolivia with the goal of completing a business and technology certificate in less than a year. He had already completed a B.S. in business and had dreams of founding a start-up in his home country,...

Department: Business and Management


As a former sociologist who specialized in quantitative analysis, Oana Fechete knows a thing or two about interpreting and analyzing data. She earned both bachelor’s and master’s degrees in sociology in Romania, where she worked in qualitative and...

Department: Business and Management, Engineering, International Program


Within a year of completing her certificate in Internet Programming and Development, Supriya Premkumar has already launched a series of successful mobile apps. When she first enrolled, she was completely new to programming, having studied mechanical...

Department: Technology


When Alejandro Jimenez completed his degree in engineering, he sensed that his education was just beginning. A native of Colombia, Jimenez wanted to find a graduate-level program that offered specialized training in embedded systems. Not only...

Department: Engineering