Divya Andy, Ph.D.
Divya Andy, Ph.D., is a pharmaceutical researcher and regulatory affairs specialist with over a decade of experience in medicinal chemistry and clinical research. She earned her Ph.D. in Chemistry from the University of Toledo, where she focused on the identification of binding proteins of calcium-mobilizing second messengers and contributed to preclinical drug safety through designing and synthesizing probe molecules. Her work has been recognized with a patent for hybrid molecules targeting cancer and metabolic disorders, reflecting her commitment to translating chemical research into therapeutic innovations.
Following her doctoral studies, Dr. Andy completed a postdoctoral fellowship at the University of Toledo College of Medicine and Life Sciences, where she expanded her expertise in clinical research, pharmacovigilance, and regulatory compliance. She has contributed to Phase II–III clinical trial designs, prepared regulatory documents for INDs and NDAs, and authored peer-reviewed safety analyses. Certified in Pharmacovigilance (CCPRS), Regulatory Affairs, and Good Clinical Laboratory Practice (GCLP), she combines her deep chemistry knowledge with regulatory and safety oversight to ensure rigorous compliance and data integrity across pharmaceutical development programs.
Currently, Dr. Andy is transitioning into roles in drug safety, regulatory affairs, and clinical research while freelancing as an AI evaluation contributor for Handshake AI. Passionate about bridging laboratory discoveries with real-world clinical outcomes, she seeks opportunities to apply her skills in ensuring patient safety and advancing innovative therapies. Outside of her professional work, she enjoys cooking and healthy baking for her family, volunteering at her children’s school, and nurturing curiosity and creativity in young minds.
• Regulatory Affairs: CMC
• Pharma Drug Regulatory Affairs Certificate Course - DRA 2026
• Clinical Research Associate Certification (CRA)
• Good Laboratory clinical practices
• Advanced Pharmacovigilance and Regulatory Affairs Training
• The University of Toledo - Ph.D.
• University of Toledo travel Award 2017
• Toledo local section ACS travel award
• Division of biological chemistry travel award
• AICTE scholarship for Master of Science in pharmaceutical chemistry 2009-2011
• School Volunteer
What do you attribute your success to?
I attribute my success to myself and my hard work through these years. It might sound overconfident, but it's definitely my hard work that got me through this. Coming to the United States from another country as a student, navigating the cultural transformation, getting my PhD, being part of a patent, and being the first and only person in my family to earn a PhD - all of this happened because of my sustained effort and dedication.
What’s the best career advice you’ve ever received?
The best career advice I received from my postdoctoral mentor was to pursue what I find fascinating. He encouraged me to go into whatever field I found fascinating, and when I expressed interest in clinical research, he supported that direction. He is an expert in metabolism and drugs, and he gave me knowledge about those areas, which helped me further understand how medicine works in the human body. This knowledge has been invaluable as I transition into clinical research, where I can evaluate new drugs and understand their effects.
What advice would you give to young women entering your industry?
My advice to anyone entering this field, not just women, is to follow your passion. You need to follow what your passion is about - that's where success peaks. If your passion is in research, please do go through with it. I will say that initially it is definitely harder because it's not a 9-to-5 job. You need a lot more hours if you really want to see progress in research. You need to prepare for hard work initially, but then things will take you through. It's rewarding when you find something, even though the long hours can be challenging.
What are the biggest challenges or opportunities in your field right now?
In terms of gender representation, I would say there are more men in certain areas like clinical research coordinator positions where you need a lot more traveling. With household responsibilities, traveling can be a little harder for women. However, clinical research is not just about clinical trials - there are so many other areas around it, like regulatory affairs and clinical science, where you can design the programs for trials. I don't think the field is dominated by men; it's equally represented by women. There are many opportunities for women to go into various facets of research, including clinical work and data management.
What values are most important to you in your work and personal life?
Being ethical and honest are the most important values to me. When errors and things happen, they should not be hidden. I believe in saying, 'Okay, I did this, now I can correct this,' or making sure it doesn't happen again. Honesty is something I always believe in, along with accountability and integrity. If you look at clinical research, the main foundation is built on these values. Imagine if someone doing a trial gives the wrong information - think about how badly that can affect the lives of people. That's why ethical work, accountability, honesty, integrity, and commitment are essential in both my professional and personal life.
Locations
Private Practice
Ypsilanti, MI 48197