Before I started my career full time in Regulatory Affairs, my view of it is that Regulatory Affairs gets involved in multiple areas of drug development and as someone who has experience in different areas, i felt it would be a perfect fit for me. But I started pondering about “What is Regulatory Affairs” not until someone asked me what do I do and what it means?. I realized I never articulated it for myself.
I have been working in this profession for about 3 years as of this writing. But when I stumble across this question, i usually do not define in a way I used to about my previous jobs (It was much easier to answer what I do while I was working as a non-clinical scientist in academia or a drug product development scientist in Industry).
Here is how that conversation goes:
My initial responses to someone who asks me what I do in career: “I work in Regulatory Affairs”. At least people outside of Pharmaceutical/Biotech space ask me “what is regulatory affairs”. I tell them, I liaise between regulatory agencies such as FDA and Sponsor company.
“What does that mean?” – They exactly want to know what is it?
I respond “I submit different applications to FDA to perform clinical trials or for approval of drugs to market them”.
“Ohh……..So you do document management then”.
“Yes, it is part of it but i work on regulatory strategy too”
“What is regulatory strategy?” They ask.
“Regulatory strategy involves collaboration with different subject matter experts (clinical, non-clinical and quality teams) to drive drug development and overcome any hurdles in developing and marketing of drugs.
Fact is that Regulatory Affairs is all of the above things, it has strategy component to it, writing component to it, document management component to it, project management component to it, leadership component to it and probably there are few other components that I am not aware of. All these are different roles and responsibilities within Regulatory Affairs but do not define what Regulatory Affairs is.
After couple of such conversations, I felt I really need to know “What Regulatory Affairs” is and should be able to define it precisely during my next such conversation. I started looking it up.
This is when I learnt that “Regulatory Affairs” is created fairly recently from the desire of government and pharmaceutical companies to protect public health by controlling the safety and efficacy of different products.
One book defined regulatory affairs as: “As a discipline, regulatory affairs covers a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised”.
Another book suggests that “Regulatory affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the FDA or the International Conference of Harmonization (ICH)”.
Another book noted that “The Regulatory affairs department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market”.
Please note that the above books gave a detailed definition and I put a concise version above.
Eventually, I came up with my own answer for it:
“Regulatory affairs is a core that holds different parts of pharmaceutical/biotech industry together from discovery phase through marketing and life cycle management and it acts as a bridge between Regulatory Authorities, Industry and public”.
I believe many professionals working in Regulatory Affairs and Pharma/Biotech industry in general agree with this one. The strategy, documentation, management, writing etc are actually the responsibilities of Regulatory Affairs professionals.
If someone asks me next time, I know what to answer.
