Jyotiska Chaudhuri’s résumé is impressive.

• Ten-plus years of research experience in molecular biology, understanding genetic polymorphisms, gene mapping, allelic variants, pathways of metabolic disease and designing drug screens.
• Independent research to understand gene regulation using various gene-expression tools.
• Published author in peer-reviewed research articles in front-line scientific journals and consumer-friendly scientific blogs, and editor of 20-plus research protocols for scientists.
• Presenter at national and international conferences and recipient of five academic awards.
• Ph.D. in Quantitative Biology from the University of Texas at Arlington.
• Postdoctoral Research Fellow at the premier Buck Institute for Research on Aging, understanding the mechanisms behind age-related complications in diabetes

And now a graduate of our Professional Program in Regulatory Affairs.

“Although I have always been passionate about fundamental research, my long-term career vision is to be closer to patient care and bring direct impact to patients' lives," Jyotiska says of choosing our program. In assessing his future career path, Jyotiska realized a gap in the timeline between bench-side discoveries to bedside treatments. This gap, Jyotiska believes, is due to regulatory trends that drive decisions on whether a treatment will make it to the patient.

In order to better understand and alleviate this bottleneck to improve patient care, Jyotiska registered for the Regulatory Affairs program.

In addition to a core curriculum, the program is intelligently designed to cater to the diverse needs of the students through a wide variety of electives.

What drew you to our program?

I want to be a part of an educational journey to learn the intricacies of pharmaceutical regulation. In addition to a core curriculum, the program is intelligently designed to cater to the diverse needs of the students through a wide variety of electives.

More importantly, I wanted to train myself through courses that align strongly with the real-world regulatory issues faced in the pharmaceutical world.

How does earning this certificate fit in with your Ph.D.?

Having a life science Ph.D., I have a deep understanding of science and have developed strong analytical skills to solve intricate problems. The thing that was missing to transition into the regulatory landscape was the necessary working knowledge of pharmaceutical regulation. The courses nicely bridged that gap, covering a range of topics such as submission procedures to agency interactions to compliance considerations. This is indeed a detailed program!

Considering that many classmates were from different branches of pharmaceutical industries, this is a great experience to get first-hand understanding of real-world client problems and learn how to address them.

You found the coursework to be practical in nature. What was your experience with the instructors?

My experience was particularly stimulating not only because of the course design, but also because of the mentors and instructors who have extensive backgrounds and experiences in pharmaceutical regulation.

The classes are extremely interactive, giving me opportunities to share my ideas openly and interact with both my classmates and instructors. Considering that many classmates were from different branches of pharmaceutical industries, this is a great experience to get first-hand understanding of real-world client problems and learn how to address them.

You’ve transitioned to a new career role. Where are you working?

I will be working in an advanced-level position within Quality Systems and Operations team in the Advanced Surgery Division at Baxter International Inc. I will mostly be analyzing deviations in processes that can affect the quality of a critical care product used for cardiac and spine surgeries. Following this, this position entails coming up with strategies to address deviations or compliance issues, in addition to communicating with the FDA for approval of necessary regulatory amendments.

What does earning the certificate mean for you personally and professionally?

This certificate was worth pursuing, not only because of the tremendous educational value but also the great networking opportunity with some fantastic classmates from a wide array of pharmaceutical industries. That was incredibly helpful.

What advice would you give someone who is thinking about starting the regulatory affairs certificate?

Stay focused and take the homework and assignments seriously as they genuinely complement the courses in gaining real-world client experiences. Network with your peers and try to gain their perspectives from the industry. Good luck!