Pharmaceutical Regulatory Affairs Jobs

The Regulatory Affairs profession has developed from the desire of governments to protect public health by controlling the safety and efficiency of products in areas including pharmaceuticals, biopharmaceuticals, veterinary medicines, medical devices, combination products, agrochemicals and cosmetics.

The roles within regulatory affairs are very diverse. ProClinical offer vacancies covering regulatory clinical development, post licensing, labelling & artwork, compliance and chemical, manufacturing & control (CMC), ranging from officer right up to director and VP level. A typical employee within regulatory affairs will ensure that the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products are undertaken in order to certify the safety and efficacy of products. Regulatory employees combine their knowledge of scientific, legal and business issues to ensure that products are developed, manufactured or distributed by a wide range of companies and meet the required legislation. They advise on and coordinate the approval and registration of 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 US, and the European Medicines Agency (EMA) for centralised, EU-wide licenses.  

A career in regulatory affairs demands the ability to tackle data in a wide range of scientific areas and to quickly grasp new concepts and complex technical information.  Most regulatory professionals possess a degree in a scientific discipline, commonly life sciences or pharmacy, although increasingly biotechnology-based degrees are valuable. Working in Regulatory Affairs requires refined skills in written and verbal communication, good attention to detail and a broad understanding of the drug development process. Analysing issues and presenting both written and oral evidence before a panel of experts such as scientists, pharmacists, doctors and lawyers who run the government agencies requires considerable understanding of scientific matters and changing regulations. Being proactive is also important for regulatory affairs positions and project management skills help to achieve the challenging goals that are set. Candidates also need to be able to work as part of multi-disciplinary teams and lead them when necessary. 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.