- April Raj

Term : December, 2015
Department : Biosciences
Program : Regulatory Affairs

After completing her undergraduate degree in biology, April Raj worked in a lab before transitioning into a regulatory affairs role. Soon after starting her new position, she discovered UCSC Extension’s Regulatory Affairs program to expand her understanding of the industry and her place in it. Although she temporarily left the field  to pursue her master’s degree in biology, she knew she wanted to build a career in regulatory affairs and made it a personal and professional goal to complete the certificate program upon returning to the industry. She completed the certificate in late 2014.

What brought you to UCSC Extension?

When I first started my career in regulatory affairs, I wanted to get a better understanding of not only my job function, but also the broader role that regulatory professionals play in the industry. I saw that regulatory affairs had a unique position that allowed interaction with almost all aspects of the business. Not only was a technical background important, but ultimately, having a broad understanding of regulatory affairs was also critical. UCSC Extension offered the essential components that I was looking for in a certificate program: a structured and well-rounded curriculum, instruction by seasoned professionals, and live courses that would facilitate discussions essential to grasping the material.

What courses stood out to you?

Although “Drug Development Process” was a challenging class, I came away from it learning a lot. Other courses that added value and were of interest were “Regulation of Drugs and Biologics”, “Good Clinical Practices” and “Regulatory Submissions: Drugs and Biologics”.

In “Regulatory Submissions: Drugs and Biologics” we had to put together an Investigational New Drug (IND) application, which is what a sponsor submits to FDA before an investigational drug can be tested in humans. For our class project, the instructor had us select and research an FDA-approved drug in order to reverse engineer an IND. This was an especially practical project because an IND is something that all regulatory professionals will encounter in their careers.

How have you been able to apply new skills at work?

Through the coursework and classroom discussions, I was able to develop a deeper understanding of the topics and issues that are encountered by regulatory affairs professionals. Additionally, the program further reinforced and enhanced the knowledge and skill set that I gained through on-the-job training. The coursework allowed me to develop a strong foundation in the basic concepts and regulations that encompass the field. I’ve been able to build upon these strengths as I’ve progressed in my career.

I would definitely recommend taking courses offered at UCSC Extension, as they provide a solid framework for learning the fundamentals of regulatory affairs. The program is not only a good fit for people with no prior experience who are interested in transitioning into the field, but also for budding regulatory affairs professionals.

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