An atyptical progression into regulatory affairs - Jack O'Reilly, Regulatory Affairs Officer & Deputy QPPV, DDD Ltd
My progression into regulatory affairs was a bit of an atypical one. I started working in research laboratories after leaving college and then starting my BSc with the Open University, graduating last year.
After some travelling I decided a change of career path was needed and ended with a job as a regulatory administrator, as the compliance side of the role appealed to me. This lasted for a year and then moved onto a full regulatory affairs position and later combined it with pharmacovigilance work.
The best part so far has been the amount of new information that I have learnt in starting a role in regulatory affairs and the contacts that I have made along the way, especially at the TOPRA meetings. With my BSc in hand I am now studying for my MSc to further progress both my knowledge of medicines and hopefully to give me the extra edge on career progression, and this will open more opportunities to me in the future.
Ways into Regulatory Affairs - Darren Whyte, Senior Consultant - Regulatory Affairs, ProClinical Ltd, UK
Unlike most vocations within the Pharmaceutical Industry, entry into a career in Regulatory Affairs does not have a set pattern or follow a natural progression. There are rarely graduate entry, internships or work placements on offer, yet a move into Regulatory Affairs is considered as challenging, exciting and offers a rewarding (financially and personally) career.
As Vice President of PAREXEL Consulting in Europe, I am responsible for the management of PAREXEL’s consulting staff operating throughout Europe.
Prior to my current role, I was Senior Director, PAREXEL Consulting, and ran the UK office. Before that, I served as Director and as Senior Regulatory Consultant, Worldwide Regulatory Affairs. I have been with PAREXEL since November 1998.
With his degree in Biology at Oxford Brookes University followed by a Masters in Environmental Science at the University of Aberdeen, Graham Donaldson thought he would eventually forge a career for himself in the environmental sector. But when an opportunity to work in Regulatory Affairs came along, Graham took it, and for the past four years he has been building his expertise at TRAC Services, a consultancy based in Cornwall. Here, he shares his experiences and explains how new graduates can follow in his footsteps.
Dr Zubair Hussain has had a career in regulatory affairs spanning 14 years and is currently Head of Country Regulatory Affairs, Europe/EEA/Australia & NZ at Pfizer, where he has worked for five years. Prior to working at Pfizer he worked at Pharmacia - later taken over by Pfizer - and Wyeth. He is a qualified pharmacist, has a D.Phil (PhD) from Oxford University and an MBA from the London Business School.
Regulatory affairs plays the key role of ensuring that safe and effective medicines are brought to the market as quickly and efficiently as possible, for the benefit of patients. So how can the profession encourage talented scientists and healthcare professionals into this demanding, yet rewarding, role? Janice Kirby-Smith from NDA Regulatory Science considers the issues