The regulatory affairs function of a Pharmaceutical and biotech company ensures legal compliance. Learn all about working in regulatory affairs.
As a regulatory affairs professional you are responsible for ensuring that every product your pharmaceutical, biotechnology or medical device company sells has the relevant licences. Patient safety and product effectiveness are key. Rules and regulations across the globe keep changing, so it is essential that you are on top of these and understand the impact on your company. Your job also includes maintaining efficient communication channels. This ensures that anything that falls under regulatory affairs, such as approval processes, runs smoothly. You might work as a Regulatory Affairs Manager or a Regulatory Affairs Officer, and be involved in:
Working in regulatory affairs varies according to the size and type of organisation you are working for. For example, this may be a pharmaceutical company, a clinical research organisation, a consultancy or even one of the regulatory bodies itself. Larger organisations will have a bigger department, which may be divided into different specialisms. A smaller organisation will have fewer staff. Here, you are likely to come across a variety of different tasks in different specialisms in regulatory affairs. This will help to broaden and develop your experience.
Regulatory affairs in pharma means securing approval for new drugs and treatments. This ensures that the products have legal permission to be released on the market for sale. The regulatory affairs department acts as an intermediary between the company’s project teams and the regulatory bodies.
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A career in regulatory affairs can provide you with a broad range of opportunities, with the potential to work in multiple capacities. Are you passionate about working in regulatory affairs in pharma? Would you be interested a job where you are helping with the registration procedure and in obtaining trading licences for medicines? Would you like to optimise the texts in package leaflets to make patient information more universally understood? Do you want to be the crucial link between the pharmaceutical company and the regulatory bodies? Can you translate the requirements of the US and European regulations to local legislation? Then this could be the right job for you!
Entry level regulatory affairs jobs may be available as a Regulatory Affairs Officer (also known as a Regulatory Affairs Associate). You can rise to more senior roles as you become more experienced.
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