How did you get into regulatory affairs?
My first taste of this profession came when I was asked to register a product with the Pharmacy and Poisons Board in Kenya. Knowing nothing about what this entailed, I casually walked into the office of the Chief Pharmacist at the Ministry of Health in Nairobi to ask how to achieve this. To my great surprise, not only was she helpful, but she took a whole hour out of her busy schedule to explain the basics. This engaged my interest to such an extent that I undertook studies to obtain the MSc in Regulatory Affairs. I subsequently progressed to become one of the Assessors at the Pharmacy and Poisons Board, Kenya.
What is your current role/area of work?
My current role at Norgine Ltd is a specialist one, undertaking regulatory due diligence activities for medicinal products and medical devices. In this role, I am required to be very flexible and willing to learn and deliver, often to very short timelines, on competing projects simultaneously.
I work on a wide range of opportunities: from ATMPs in development to established marketed products (and anything in between), on a wide range of medical devices and on activities from scientific advice, PIPs, CTAs, MAs submissions and post-approval strategies to implementation of in-licenced products. The size and complexity of the companies involved ranges from SMEs to university spin-offs to multinational corporations.
What challenges/opportunities did you face advancing up the career ladder?
In terms of challenges, there were two major challenges and some smaller ones.
The first challenge was my initial lack of experience in the regulatory field, and the opportunity to grow within this field. In Kenya, regulatory affairs was not considered a critical business function.
My role as Operations and Regulatory Affairs Manager in Kenya required a certain set of skills, knowledge and experience, including business development, profit analysis, etc, which I have built whist facing many responsibilities and challenges. These skills have been hugely rewarding in my career progression both in Kenya and here in the UK.
The second challenge was that I had to climb down the career ladder when I relocated to the UK in 2008. I joined Teva UK Ltd as a Regulatory Affairs Officer, and had to work hard to progress and establish myself – I felt I had to work harder than anyone else – and in so doing I advanced to the Principal Regulatory Affairs Officer position, until we parted ways three years later.
In terms of opportunities, firstly, I had the opportunity in Kenya to work on medicinal products from a wide range of therapeutic areas, with medical devices and with a wide range of companies (multinational companies, generic companies, SMEs, CMOs).
Secondly, I had the opportunity to study and get my MSc in Regulatory Affairs, where I was the recipient of the Murray Howitt Prize. Later, at Norgine Ltd, I was able to study for and get the Post Graduate Diploma in Industrial Pharmaceutical Studies.
What does diversity mean to you as a regulatory affairs professional?
Firstly, as a British Kenyan of Indian origin, I can appreciate diversity. As an individual, and as an employee, I have been exposed to many cultures, backgrounds and religions, and have a great appreciation of the diversity and differences therein. Throughout my career I have worked with people from all over the world, learning about differences in cultures and expectations and ways of doing things. This has enabled me not only to be adaptable and flexible in my approach to various situations, but also to appreciate and respect differences in beliefs and culture.
As a regulatory affairs professional, embracing diversity allows me to engage across different spaces and opportunities in different and innovative ways, using differing cultural values to achieve common goals – challenging yet rewarding.
What tips do you have for other TOPRA members about utilising diversity to improve business performance? How can focussing on diversity impact business outcomes?
Diversity is part of today’s organisations – embrace it, use it. It does require a nurturing environment to bring positive outcomes. Make your organisation’s environment a nurturing one and you and the organisation will benefit without fail.
Here at Norgine we embrace diversity and believe it brings unique experiences to groups and teams. Leveraging individual strengths and complementing weaknesses of individuals make the impact of the workforce greater than the sum of its parts. Being exposed to new ideas, cultures and perspectives can help individuals grow and strengthen relationships inside and outside of the company.