Research to Regulation: the Career Journey of Alumna Rajni Singh

By Janani Hariharan

Do you care about animal safety and well-being in research and veterinary medicine settings?  Did you know that you, a PhD student or postdoctoral researcher, could choose among various career paths focused on animal safety?  These kinds of careers are just some of those that fall under the broad term “regulatory affairs.”

As part of the BEST program’s efforts to help PhDs and postdocs become more aware of our future career possibilities, Dr. Rajni Singh, Consumer Safety Officer at the FDA and a Cornell alumna, walked us through her path.  She was invited to Cornell by Jin Liang, postdoc at the Weill Institute for Cell and Molecular Biology and BEST Advisory Board member. A group of BESTies, old and new, met with her on campus and heard her emphasize the importance of her PhD research, an excellent postdoctoral fellowship, and great mentorship in her current workplace.

While at Cornell, Rajni’s research involved pharmacology and neurotoxicology, making it necessary to work with lab animals. This laid the foundation for her strong technical know-how about current government regulations regarding animals used in experiments, and their effective practice in the laboratory setting. Being a regulatory affairs officer was not always her goal though – as an undergrad, she wanted to become a professor.

Dr. Ranji Singh at Cornell. Photo credit: Susi Varvayanis

However, during her time as a PhD student and a postdoc at NIH, she realized how stressful benchwork could be, and how rare faculty positions are. She talked about the importance of access to career development resources as a graduate student and postdoctoral trainee, and believes that NIH’s research and career resources were a huge aid in identifying her ideal career. Additionally, her experience with the Center for Teaching Innovation at Cornell aided in developing public speaking skills which are extremely useful in her current job, and indeed, in many other jobs.

Although she was making progress at her postdoctoral stint at the NIH, she decided to take a risk and apply for an ORISE fellowship. This was a risky decision because it meant a switch from a successful academic career to a non-traditional one, but Rajni’s motivation behind this decision was to experience a new career track, and her new supervisor was ready to support and promote her growth as a mentee. This decision proved to be a good one as it became a stepping stone to her current position. The ORISE fellowship created an opportunity for a short-term regulatory affairs stint at the FDA, which eventually led to the title of Consumer Safety Officer that Rajni holds today.

One of the major advantages of a government career off the bench is the work-life balance, as there are no experimental timepoints and team members recognize that people have lives outside of work. This could be especially useful for people who enjoy a regular routine and steadiness of pace. On the negative side, the FDA (indeed, government) employees are prohibited from investing in companies regulated by the FDA, which could be a setback for some people. There might not be as much room for advancement to senior positions, which also impacts the payscale, and the pace of work tends to be slower than that seen in industry.

Rajni’s story generated a lot of interest and curiosity about the career track itself, as well as her journey and decision-making process. In response to questions from graduate students interested in regulatory affairs, she said that it is not necessary to have previous experience in regulatory affairs, since a lot of teams are strengthened by individuals from interdisciplinary backgrounds. Additionally, the FDA (like other regulatory bodies) provides mandatory training to employees which includes information on the U.S. legal code, legal writing, and research ethics training.

So, what does a regulatory affairs officer do on a daily basis? Rajni stresses that this career is an ideal fit for someone who is detail-oriented and likes to be meticulous and thorough in their work, as opposed to people who might be big-picture thinkers. She is currently located in the Center for Veterinary Medicine (CVM) at the FDA, along with 500 other employees. Her responsibilities involve working with drug sponsors to regulate the sale of animal drugs after they have received FDA approval (otherwise called surveillance). This involves collecting data about drug trials and promotional materials from sponsors (drug manufacturers), reviewing them for potential problems, working with the sponsors, and writing reports. As part of a larger team, she conducts literature reviews and data analyses, compiles information for supervisors and policy officials or even members of Congress, liaises with lawyers and veterinarians, and deals with emerging themes in the animal health industry such as antimicrobial resistance. Additionally, she is sometimes asked to be a part of working committees that amend existing guidelines and gather input from stakeholders. In rare cases, non-compliance with FDA regulations may result in drugs being pulled from the market, and a regulatory affairs professional has to make those decisions and contact the drug manufacturers. Naturally, this involves dealing with confidential data and meetings. Ideal qualities for this career track include: attention to detail, being a team player, and the ability to communicate science to multiple audiences (scientists, regulatory professionals, policy makers, and the general public).

For students and postdocs interested in a career in Regulatory Affairs, the BEST program provides ample resources.