How did you get into regulatory affairs?
It’s a good question because there is no dedicated regulatory affairs degree out there, and limited regulatory affairs modules in most science courses. Most people don’t know what it is that I do! I’ve always been interested in science, and specifically chemistry. When I finished college, I went straight into a lab environment but quickly realised that it wasn’t for me. I was performing analytical testing and validation, but it was the same tests, and I wondered about the reasons for this. Turns out it was to do with European regulation, and that piqued my interest. I was lucky to have an understanding boss who sent me off to the regulatory affairs department to take a look – I never came back!
What is your current role/area of work?
Currently I run my own regulatory affairs consultancy business in Clonmel, Ireland, called Ivowen Limited. We are small (currently 7 people), but very knowledgeable and efficient! We cater mainly to the generic pharmaceutical industry, both human and veterinary drugs. We work with a lot of start-ups, which is both exciting and challenging, and we are truly multi-national, with clients from as far flung as New Zealand, South Africa, China as well as plenty of European customers. Lately we’ve had more interest from companies with new chemical entities and new ideas, which makes it very interesting and challenging – as new drugs are the future.
What challenges/opportunities did you face advancing up the career ladder?
I think I progressed reasonably quickly up the career ladder when I was working in industry, probably because I found my niche. I found that regulatory affairs combined the structure that the "rules" side of me liked and the opportunity to come up with action plans for projects that didn’t quite fit the mould for my creative side. I am sure that a lot of people wouldn’t consider regulatory affairs very creative, but trust me, if there’s a rule then there’s a way around it.
I found more opportunities than challenges in my career, and discovered quite early on that if you want something, you can ask for it and get it – as long as you have a plan to get there. Ivowen was set up on the back of my company at the time going bust in 2002. It was a challenge to grow the business from nothing, and it is challenging daily to run a small business in a competitive and highly regulated environment, but 15 years later we are still here, going strong.
What does diversity mean to you as a manager and/or an RA professional?
I embrace and enjoy diversity tremendously! As a regulatory affairs professional who deals with people from all over the world, I relish the opportunity to visit other countries, sample other cultures, take the best of what somebody else does and try to integrate it into my professional and personal life. For me, we are all people, and people are the same the world over – we all want to be happy, live hopefully long, happy and healthy lives, enjoy our loved ones, and contribute to society in some small way. Every single person has something positive to give if you give them a chance, and we all deserve that.
What tips do you have for other TOPRA members about utilising diversity to improve business performance? How can focussing on diversity impact business outcomes?
The pharmaceutical world is a global community. Unfortunately we all get sick at some stage, and we all can benefit from access to medicines. Having a diverse and varied workforce, made up of different sexes, nationalities, backgrounds, abilities, etc, opens the door to understanding the regulators in different countries. If the EU MRP/DCP/CP system has taught us one thing, it’s that we are one single market but we are all individuals. Our focus, and the assessors’ focus, is dependent on our own personal and cultural point of view. Understanding, or at least appreciating, each other’s culture and background can only help pave the way to successful communication and outcomes.