From Research to Regulatory Affairs--Long Journey to a Complete Life Cycle


Editor's note: Yatika Kohli, a Canadian regulatory affairs specialist, describes her career transition from a Ph.D. research scientist and notes the important decisions she had to make along the way.

Fourteen years ago, I came to Canada from India with a dream. My clear goal and only focus was to acquire a higher education from a reputable university in Canada. So I headed straight for postgraduate studies at the University of Toronto, without taking the time to weigh up my job options before embarking on my studies. At that time, everything seemed to make sense from the perspective of family, geography, and fulfilling my dream and desires.

I was accepted into the University of Toronto's M.Sc. program in molecular biology. I was happy with the research project, made good progress, and became comfortable with the lab and the work, so I went on to do a Ph.D. in the same laboratory. Now looking back, this transition could have been yet another opportunity to assess the job market. I didn't explore the possibilities available to those with a master's qualification, even when my peer in the private sector prodded me by asking about my future plans. I failed to realize at the time that this could be a potential opportunity for a job. It was during those arduous years of a Ph.D. that I discovered my interests in applied research and realised the potential challenges of a career in academia. In my mind, I wasn't prepared to chase after the ever-diminishing research funding and scarce academic positions. So after my doctorate, while I was still indecisive about pursuing academia, I decided to make a transition to clinically applied research.

I took the middle road between pure academia and industry and accepted a prestigious postdoctoral fellowship at the Hospital for Sick Children in Toronto for 2 years. The work involved developing methods for the molecular diagnostics of Candidiasis (a common fungal blood stream infection found among children born prematurely and/or with a very low birth weight) and conducting in vitro drug susceptibility testing to identify strains with drug resistance. On a part-time basis, I also tried my hand at Web-based teaching for a biotechnology program at a local college. Upon completion of my postdoc program, I continued working as a researcher, managing the laboratory, training personnel, and designing innovative methods for application in microbiology laboratory diagnostic tests.

From Research to R&D

As a researcher at the bench, the ability to investigate new ideas while enjoying the relaxed and cordial work environment excited me. Nonetheless, I often found myself soul-searching, looking for opportunities of growth and a more dynamic career. I realized I was yearning for an opportunity to get exposure to and understanding of the processes involved in the development of a therapeutic/biotech product relative to the postclinical research phase. I was ready to leave the bench and explore the dynamics of research and development in the private sector and be involved in the product development phase of clinical research. I was confident of my potentials, creativity, and eagerness to learn--I just needed an opportunity to prove it.

One of my first challenges was to identify areas of the private sector where I could apply my experience and skills acquired during postgraduate studies, such as project management, design and execution skills, as well as writing skills. After talking to my peers, colleagues, and friends and participating in networking meetings such as breakfast meetings held by the Toronto Biotechnology Initiative, I recognized that regulatory affairs and medical writing were the two possible functions in the private industry that I could pursue. I knew that the job search was going to be hard to begin with, but it would become even harder with the added element of being geographically restricted; because my husband already had a stable and progressing career, it was difficult for me to move elsewhere.

I followed all the rules of job-searching 'to the book'. I made sure that my resume was impressive and targeted, posted my resume at all possible job databases and company Web sites, applied for every relevant position advertised, attended job-related seminars, conducted self-education on relevant and interesting topics, explored contacts in both academia and the private sector for further leads, and requested informational interviews.

My perseverance and patience finally paid off when an employment agent contacted me regarding a possible opening in a reputable biotechnology company. After going through rigorous interviews and written tests, and with luck in my favour, I was deemed suitable for two positions--regulatory scientist and medical writer. Being clear about my objective, I opted for the regulatory scientist position. This position offered a dynamic environment and exposure to all processes in the life cycle of a biological product (research to launch, commonly referred to as R2L). Because the company was moving into the new era of 'paperless electronic submissions', my online teaching experience came in handy.

Life as an RA Specialist

As a regulatory scientist, my primary job is to coordinate functions for the delivery of quality documentation, project, and regulatory files to the governing agencies. At any given time, I may be working on one mega project or several smaller projects, in groups or task forces, but the ultimate goal is to deliver a quality project on time. This position also requires interaction with other departments within the company to give advice on regulatory guidelines and requirements. To do this effectively, technical and professional expertise is necessary, and it is important to have a clear understanding of the speciality area as well as familiarity with the specific regulatory guidelines. I am still on the learning curve and have been continually educating myself by taking courses and attending relevant workshops both on-site as well as those offered by organisations such as CanReg Inc., Pharmaceutical Sciences Group, and Barnett Educational Services.

In regulatory affairs (RA), one gets a flavour of the dynamic nature of the private sector, as priorities can change overnight. Imagine how you would feel as the key researcher in the laboratory if your pet project was being shot down! At the same time, even the projects that are active evolve continually as a result of advancements in technology or specific directions from the governing authorities.

Within RA, employment opportunities generally increase when any product is nearing an application to start the investigations (clinical trials), referred to as Investigative New Drug (IND) applications, or at the time of license application, called Biologics License Application (BLA) or New Drug Submission (NDS). At my company, the RA department has grown five-fold in size over the last 5 years. Typically for a scientist-level position, individuals with at least a master's degree plus 2 to 3 years of RA experience or with a Ph.D. degree are sought after. The skills acquired during postgraduate studies, including time/project management, organization, teamwork, attention to detail, and both oral and written communication are all basic requirements in RA.

It has been almost a year since I have been working as a scientist in RA, and as the lead clinical RA specialist, I have found a healthy mix of being connected with the research as well as being exposed to and responsible for project delivery, dossier quality, and response to questions by various regulatory agencies (e.g., the Food and Drug Administration and Health Canada). I can still remember the mixed response I received from my academic colleagues and friends when I decided to make this career transition. Some thought that it was a good opportunity and experience in RA would make me more marketable in industry, while others perceived it to be merely handling large documents all day long ("looking at pages and pages", as they referred to it) and assumed that I would quickly become bored.

Although the amount of paperwork involved in this job can be overwhelming, the variety of documents is so diverse that there is never a dull moment. There were also discussions amongst friends about the perceived downside of being dependent on others to complete any job, which can add to the frustration level. This, in my opinion, is the biggest challenge for a core researcher who is used to being very independent. Of course, there are always the politics and bureaucracy that no one can escape, whether in academia or the private sector. But as for most jobs, all that is required is to develop some thick skin and do your job to the best of your ability.

While experiencing and enjoying this career transition, I always preach the golden rule that 'hard work and perseverance does pay off'! So keep at it--there is light at the end of the tunnel.

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