Tell us about Pharma Regulatory Affairs?

Have you ever considered what the world would be like without pharmaceutical drugs? Or clean drinking water? Or food from the supermarket that is safe to eat? Millions of Americans depend on products and services for their health and well-being everyday such as over-the-counter drugs that treat everything from common colds to rashes. These almost indispensable products would not be available if it weren’t for the valuable information provided by regulatory affairs (RA) professionals in government and industry.

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While the Food and Drug Administration (FDA), for example, is responsible for making sure that each pharmaceutical product offered to the consumer is safe and effective, it must rely on RA professionals who specialize in the complicated drug approval rules. Other agencies such as the U.S. Department of Agriculture, the Environmental Protection Agency, the Occupational Safety and Health Administration, and the Drug Enforcement Administration also rely on RA for expertise. RA professionals not only keep up with American regulatory standards, they have to be just as proficient in drug development rules in other countries.

RA professionals come from a variety of disciplines such as law, academic and industrial research, and medicine. RA is a promising field for scientists searching for alternative careers because it offers a multitude of starting jobs and opportunities for advancement. Check out this month’s spotlight on the world of RA.

What did you study?

I had always wanted to be a paediatrician. I began my journey towards a medical degree by joining the bachelor’s program in life sciences at the University of Delhi, India. After completing the first year, I wrote the admission test to a medical school but was not selected even after all the hard work I had put in. I continued with the bachelor’s program and later a master’s degree. My career transition had begun, not by choice I might add.

I was not even sure about what I wanted to do next. However, after exploring around for a few months, I joined a medical research project on transmission of leprosy. I enjoyed working on the project for a year and then applied for funds to support my own research project on immunological and nutritional aspects of human breast secretions. Having secured the funds, I transformed into a “paramedical research doctor” instead of a “real” doctor, hopping in and out of nurseries, paediatric wards, and pre- and postnatal clinics, collecting data and analyzing samples. Three years later I completed my Ph.D. on the same project.

What did you do next?

While I was writing my thesis, my personal status changed from single to married and also from Indian to Canadian. I had never considered leaving India, yet I landed in Toronto to join my husband who had already settled in Canada. Within 2 months of my arrival, I found a postdoctoral research position in the department of immunology at the University of Toronto. One and a half years later, I found myself at the crossroads of choosing between my career and raising a family. Like the Tortoise (see the Next Wave article, “Tortoise With a Good Spouse”), I was convinced that I had to leave research to raise a family and also that I could return to work after a year or so. So I decided to quit research and another career transition had begun: I was parenting.

I was happy being a mom; however, I took an offer to run a clothing business, which involved importing and exporting ladies’ clothes. Initially, it started as a home-based project and soon expanded into two retail stores. Soon, I found myself selling clothes instead of immunizing mice or running ELISAs, and enjoying it. I could spend time with my family and also had the satisfaction of running a business and financially supporting my family. I managed the clothing business for about 4 years.

As years went by, I felt restless; I missed the laboratory, the mice, the test tubes, and ELISA plates and wanted to go back to research. I started applying for research positions and realized that it was not easy to step back into academic or pure research. Not only had science advanced beyond my imagination in the years I had been away from it, I could not return to the uncertainty of long hours running the experiments. I started looking for positions in the private industry where I could use my training and experience gained during my Ph.D. and at the University of Toronto.

How did you end up in such an offbeat, unconventional and unique career?

After weeks of job hunting, I accepted a part-time position as the technical advisor in a small company dealing in rapid immunodiagnostic tests and kits. Once again I was speaking the language of science, dealing with people in the pharmaceutical industry, both local and international. I was also familiarizing myself with the laws, rules, and regulations for importing and exporting and marketing of medical devices. This position became the inroad into the pharmaceutical industry.

My interest in regulatory affairs grew, and 2 years later I registered at Seneca College in Toronto for a full-time postgraduate course in regulatory affairs and quality assurance. It was the pivotal turning point for my future career. At the end of a seemingly long 12 months of juggling family responsibilities, evening classes, and late-night assignments, I was educated in the international laws and regulations that pertain to the manufacture of drugs, biologics and medical devices, research and development processes, clinical trials, good manufacturing practices, quality control and assurance, and validation and postapproval activities.

I graduated from the course with summer co-op work experience at a contract clinical research company that conducted phase 1 clinical trials. At the time I also worked as a part-time regulatory consultant for a company manufacturing and distributing dental products (medical devices).

What was your career path?

A few months later, I joined Aventis Pasteur Limited, Canada’s largest vaccine company, manufacturing or distributing 30 vaccines and immunotherapeutic products, which protect against 17 infectious diseases and common illnesses. I worked in the research and development department, tracking test development and validation and transfer of tests to quality control. Later, I was involved in implementing good documentation practices in the research department. And 2 years after that, I find myself in my current position as a project specialist in the Product Licensing Group, Industrial Operations.

The project specialist position is a bridge between the product manufacturing and regulatory affairs departments and involves collating information and writing submissions for new products, facilitating postsubmission questions from regulatory agencies, and tracking completion of postlicensure commitments. The position offers excellent exposure to all phases of development of a biologic product, from research to launch and postmarketing. I have been able to use my academic training and research experience in immunology and microbiology, combining the ability to analyze problems using scientific strategies and the knowledge of regulatory affairs and quality assurance.

What are the skills needed for this role?

Several other skills I acquired from my parenting role (juggling my time effectively and multitasking, such as cooking, changing diapers, running the business, decision-making ability, critical assessment) and as the manager of a clothing business (effective communication, people management, inventory and sales control, marketing, customer satisfaction) are also very critical to being a good regulatory professional. Unlike research, the regulatory affairs position allows the flexibility of working from home, which I appreciate, being a working mother. I am fortunate to have a very supportive husband who is able to look after the family if I need to spend long hours at work (quite often!)

Looking back, my career transition from research to regulatory affairs has been a long, winding road, where fate less than choice led my way. I like this anonymous quote, “When you come to the edge of all the light you know and you are about to step off in the darkness of the unknown, faith knows one of two things will happen: There will be something solid to stand on, or you will be taught how to fly.” And I have always been able to find the solid ground to stand on, so far at least.