How did you get into regulatory affairs?
I initially graduated with a degree in Pharmacy and, following that, I read for a Masters degree in Pharmacotherapeutics & Medicines Management in the UK. I then returned to Malta to settle in a career as a community pharmacist. However, after a number of years I realised that it wasn’t a career that I wanted to pursue. I was told by one of my undergraduate lecturers that a vacancy had become available at Actavis in their Regulatory Affairs team. I immediately applied and was successful in the selection process. I was responsible for compiling and drafting Module 3 of the dossier for generic products as well as having other development responsibilities. The job was intriguing and the team was fantastic, which made the job even more exciting and rewarding.
What is your current role/area of work?
I am currently working with a regulatory consultancy where I am responsible for a number of projects in different areas of regulatory. The diversity in the job is what drew me to it, as I can apply what I have already learnt in the past whilst being involved in new areas of regulatory at the same time. The involvement with different clients and assisting them in areas where they need insight and direction is an added bonus as this also aids in learning new perspectives, which can subsequently be applied in future projects when the need arises. The job allows me to be innovative and creative in finding solutions to clients’ issues, as well as delving into regulatory directives/guidelines, which I had never had the opportunity to explore previously.
What challenges/opportunities did you face advancing up the career ladder?
As I had started my regulatory affairs career in Malta, advancing up the career ladder was going to be a challenge since opportunities were very limited. In order for me to advance I decided to start reading for a Masters in Regulatory Affairs with TOPRA. This was a crucial step as it provided me with a gateway to a myriad of opportunities, as it became clear that it was time to move to the United Kingdom. Whilst this was definitely an opportunity, as I was making a bold move to new beginnings, leaving my family and friends (and the 300 days of annual sunshine) behind was very challenging. However, seven years later, I do not regret the move.
Fast forward three years from my move and I felt that it was time to move on from the world of generics to the world of innovator drugs. This was a challenge, since few companies are willing to take on an individual with five years of generics background into the innovator arena. However, I persevered and managed to join one of the top five big pharma companies in the oncology therapeutic area. The challenges were numerous but not insurmountable. The generics field is very fast paced – decisions are taken very rapidly. However it is very limited when it comes to regulatory procedures and strategy. On the other hand, in big pharma decision making involves several strata of management endorsement before actions are taken. It took a while until I got used to the way of working, besides getting up to speed with the countless guidelines and directives involved. Thankfully I had a good manager and great colleagues, who helped me out to form a solid foundation.
What does diversity mean to you as a regulatory affairs professional?
I believe that there is always something more to learn in any subject that one is interested in. Diversity brings along new opportunities to learn, be it from your managers, direct reports or your colleagues. No matter what their gender, ethnicity, nationality, culture or regulatory background is they bring along information that you can tap into, absorb and apply to your day-to-day job, innovating your way of working and the way you perceive issues and/or resolve them.
I have had the opportunity to work with a number of colleagues and clients based all over the world. I observed that what is seen as incorrect or even rude by some is regarded as acceptable by others. It’s a mind-opener which aids in appreciating the barriers that we face in our job but at the same time it assists one in maturing into a true professional.
What tips do you have for other TOPRA members about utilising diversity to improve business performance? How can focussing on diversity impact business outcomes?
Sometimes answers are found where you least expect them. From a regulatory perspective I have sought to gain experience in a number of different areas. Whilst doing so I have applied what I learnt in one field to another and have succeeded to resolve several issues by doing so.
I appreciate that this form of career ambition is not for everyone, but there are those who pursue it and whom should be given the chance to learn and experiment regardless of their background. In turn, they too will apply previous learnings to their new activities. Some might work, others might not, but we all should be allowed to innovate without fear of repercussions.
Having a team of professionals coming from different walks of life will help transform team dynamics, and mould the work environment into a learning and advancing working philosophy that always seeks better results. Colleagues will integrate and learn from one another, thus creating a team that is continuously evolving and changing positively, achieving more, efficiently.