What is regulatory affairs?
Regulatory affairs (RA) is concerned with achieving market authorisation for a medicinal product. In order to make a product available globally, regulatory affairs professionals must apply for licences from different government regulatory bodies, all with varying regulatory systems and requirements.
What do regulatory affairs jobs involve?
People in pharmaceutical regulatory affairs jobs advise on and coordinate the approval and registration of pharmaceutical products, submitting licensing documentation and liaising with government regulatory bodies such as the Medicines & Healthcare Regulatory Agency (MHRA) in the UK, the Irish Medicines Board (IMB), the Food & Drug Administration (FDA) in the USA, and the European Medicines Agency (EMA) for centralised, EU-wide licenses.
Jobs in pharmaceutical regulatory affairs require refined skills in written and verbal communication, good attention to detail and a broad understanding of the drug development process. Skills are typically transferrable across all therapy areas, but regulations, and therefore specialisations, do vary greatly according to the type of product i.e. whether it is an over-the-counter (OTC) product, a prescription chemical drug, a biological drug or a medical device. If you have not worked in regulatory affairs before, we advise you to read our career advice blog on how to get a job in regulatory affairs.
How ProClinical can help:
Our specialists are extremely knowledgeable in the area of regulatory affairs, which sets us apart from more generalist recruiters. Our dedicated specialists undertake thorough training and truly understand the complexities and nuances of regulatory affairs jobs across compliance, labelling, operations, associate and management roles. By understanding the skills that are required, our specialists can match you with the most suitable permanent or contract role dependant on your skills and experience and your career aspirations.
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