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.
Why regulatory affairs?
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 the market 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 is still very much on the forefront of the drug development effort. A position in the reg affairs field often brings a higher level of job security than in similar research and development positions, as 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, and once you gain 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 or provide consultative services, both options that lend itself well to working from home.
What are employers looking for?
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 must be able to recognise and rectify mistakes quickly and efficiently. Communication skills are important too; Many RA professionals deal with all sorts of individuals involved at different stages of the drug development cycle, and knowing how to manage these relationships effectively is essential.
The truth is that there’s no single requirement for candidates to enter the field. 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 are great for graduates seeking career advice. An undergraduate or postgraduate scientific degree (biology, microbiology, pharmacy, biochemistry, pharmacology or similar) is the first step in getting into RA, and experience in drug development is a bonus. Candidates who are successful in the field come with a variety of backgrounds and career experiences, the only common thread being a strong interest in the drug development cycle and information analysis.
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 accustomed to working with AI, and the ways in which people are working keep changing as we discover its 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? View our open roles, or send us your CV or question over on our regulatory affairs page.