Post date: Jul 24, 2014 2:59:23 PM

by Yang Liu

Dr. Rui Zhao is an alumna of the Molecular and Cellular Biology PhD program. Her thesis focused on spatial and temporal analysis of gene expression in living cells. She started considering her future career path in her senior years, and found her interest in regulatory affairs of the biotechnology industry. She now works in regulatory affairs at Bayer Healthcare.

How did you decide to pursue a career in regulatory affairs of the biotechnology industry? I started thinking about my career path in my senior years. Since we are not familiar with biotech industry and have little, if any, exposure to it during graduate school, I wanted to determine if I was more interested in that than academia. With this intention, I joined the Fundamentals of the Bioscience Industry Program (FBIP) at Stony Brook, which gave me the chance to learn about many aspects of biotech industry. The program sparked my interest in regulatory affairs, which aligns with my undergraduate degree in pharmacy.

Can you describe your current job? The regulatory affairs department deals with all the interactions between the Health Authorities (HA) and pharmaceutical companies. Our primary responsibility is to learn the current laws and regulations and to work with other departments involved in the company's R&D and manufacturing to ensure all aspects of our products are compliant with current regulations. As a global company we need to deal with worldwide HAs such as the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) in the EU and Health Canada in Canada. We are involved in the whole process of drug development, including from Phase I to new drug applications (NDA), and achieving successful marketing permits. In other words, regulatory affairs is the last step of the development process in R&D, because once a drug reaches the HA and gets licensed, it is ready for marketing. We also work on successful licensure maintenance of drugs in the commercial phase to ensure continuous marketing of the drug.

How did you find your current job? I learned about an internship at Bayer Healthcare Global Regulatory Affairs from an alumna of FBIP. So I applied for it, got interviewed and selected. When the internship was over, the company offered to keep me on board.

What do you like about regulatory affairs? For me, regulatory affairs is very rewarding. I am directly involved in the whole product development process from Phase I to licensure and even to post-marketing maintenance of the licensure. My input impacts product quality and success of a drug. A successful new drug will significantly improve life quality for patients .

How did you prepare for a career in regulatory affairs? Can you give some advice to current students willing to join pharmaceutical industry? I taught myself about US regulations through preparation for the RAC exam while I was still in graduate school. The Regulatory Affairs Certification (RAC) is issued by the Regulatory Affairs Professional Society, and is a well recognized certification for the regulatory profession in the US. Even though it’s not required for RA positions, many companies indicate that RAC is a desirable qualification. The more I learned about RA, the more I was interested in it. That’s why I applied for the internship to get some practical experience. Other important skills, like communication and leadership can be honed through student activities. My suggestion for current students is to learn more about non-academic careers and find your own "match" first, then to prepare yourself purposefully.

Do you think having internship experience makes a difference for non-academic job hunting? Yes, definitely. Internships benefit you not only by arming you with non-academic work experience, but also by figuring out if you truly like the field in just three months’ time.

How did you negotiate with your supervisor when you asked to do an internship? It’s up to how you communicate with your supervisor. I got my first internship opportunity from Bayer right in the middle of my thesis research and paper writing. My supervisor denied my request because I needed to stay in lab to finish things up. Even though I was very upset at the time, I think it was a very good choice looking back. My supervisor pointed out that if I did the internship in the middle of my PhD, all the industry connections I made might be lost when I returned to finish my degree. Then I asked if he would let me go for an internship after I finished my paper in the following year, and he said yes. So I worked really hard in that year and kept everything on track, managed to publish a paper in a high-tier journal and applied again for the internship. Finally, everything worked out.

What was the most challenging aspect of transitioning from academia into regulatory affairs? The most beneficial aspect of PhD training is our learning skills. PhD students have incredibly strong learning skills and analytical thinking capability. So learning the common procedures for my new position was not difficult. However, non-academic jobs emphasize soft skills, which will determine how successful you can be in the future. This includes how to express yourself clearly, how to communicate more efficiently, how to deal with politics, etc. It was more challenging to hone these skills and requires continuous improvement.

For more information about regulatory affairs, visit: http://pubs.acs.org/cen/employment/8048/8048regulatoryaffairs.html