Regulatory affairs professionals play a critical role in the pharmaceutical industry and are involved at all stages of the drug development process, providing support and direction that enables other departments involved in the process to deliver effective healthcare products across the globe. Their work ensures products are approved by pharmaceutical regulatory bodies, a vital step in bringing any new treatment to market.
Regulatory affairs has been a cornerstone of our operations for over 20 years. There is demand for professionals at each stage of the clinical trial process, and our candidate pool is made up of a diverse range of individuals from a variety of backgrounds. The tactical and strategic industry is favoured among life scientific professionals who are looking for a career that isn’t lab-based, but still want to be involved in drug development, and people looking for a position with higher job security than in similar research and development positions (product failure won’t necessarily put a regulatory affairs professional out of a job). It’s also a great route for graduates; entry-level roles are accessible for those who have a bachelors or a masters, a PhD isn’t often required. There is good career progression in within the field of RA, once one gains experience it’s easy to move from a junior administrative role into a more senior role with advisory functions. There is also the offer of flexibility, with some senior professionals opting to freelance, provide consultations or work from home.
A key trait for those looking to enter the field is a meticulous eye for detail. A huge requirement is analysing and submitting heavily technical documentation, which often has to be done toward a tight deadline to meet market launch dates. Organisation skills are essential, and you have to be able to recognise and rectify mistakes quickly and efficiently, and communication skills are important too; Many RA professionals deal with all sorts of individuals involved at different stages of the drug development cycle, and so knowing how to communicate ideas effectively is essential.
I’m often asked for advice on how to enter the regulatory affairs space, and the truth is there’s no single requirement for candidates to enter the field, and occasionally employers that offer junior roles are looking for prior experience. This makes researching roles and getting your foot in the door quite difficult, and could be enough to lead a candidate to look elsewhere. Networking is invaluable for those looking to start their career, and organisations like TOPRA and events like Regulatory Careers Live are great for graduates seeking career advice. An undergraduate or postgraduate scientific degree (biology, microbiology, pharmacy, biochemistry, pharmacology etc) is mandatory for getting into RA, and experience in drug development is a bonus. Importantly, candidates have to have a strong interest in RA, the drug development cycle and information analysis. Day-to-day I speak to candidates with a range of backgrounds and experiences, and I’ve learnt there is no one-size-fits-all template for the ideal candidate looking to begin a career in RA.
The future of regulatory affairs is bright, and as with other areas within pharma, developments in artificial intelligence and machine learning mean the RA landscape is evolving. New roles are being introduced and there are new responsibilities for those in the field; There is a growing need for people to be accustom to working with AI, and the ways in which people are working keep changing as we discover it’s full capabilities.
It’s an exciting time to be in regulatory affairs, and demand for professionals is high. Do you have questions about your next move within the field, or seeking advice on how to begin your RA career? Connect with me on LinkedIn for some further insights or to hear about our latest roles.