Regulatory affairs in the USA an overview Viewpoint careers advice blog

Regulatory affairs in the USA an overview The regulatory affairs function within life sciences companies is the bridge between the industry and governments, specifically those state organisations that are responsible for regulating the life sciences sector. In this episode, I focus on the specifics of the regulatory environment in the USA and tease out some of the factors affecting trends in both business and employment. What is the US Food and Drug Administration (FDA)? The US Food and Drug Administration (FDA) is part of the Health and Human Services department of the US government and has overall responsibility for the regulation of drugs, biological products and medical devices manufactured and/or sold in the USA. It is the ultimate authority for the protection and promotion of human health across the region and its equivalent in Europe is the European Medicines Agency (EMA). How the FDA impacts on regulatory affairs As the bridge between industry and government, it is the regulatory affairs department’s role within companies to keep track of ever-changing government legislation. Regulatory affairs departments also submit viable registration documents to the FDA and give strategic and technical advice to other departments and business disciplines, including research and development (RD) and quality assurance (QA). All new drugs, biologics and devices are subject to extensive FDA scrutiny before approval is granted. Two primary instruments are used for this purpose: New Drug Applications (NDAs) and Biologics Licence Applications (BLAs). Both of these are subject to variations such as Investigational New Drug (IND) regulations, fast-track designations, special protocol assessments and labelling and advertising specifications. Recent changes, such as off-patent drugs and cell-based medicines In recent years, many former innovator drugs have come off-patent, opening up the generics market. This has put regulatory systems into the spotlight. Following Europe’s lead, the field of biologics has also taken off, with new cell-based medicines (cellular therapies) and DNA-based medicines (gene therapies) increasingly under review for commercial development. Biologics, such as vaccines and blood components or derivatives, are not as straightforward as pharmaceuticals, as virtually every one is a novel product and their pharmacokinetics are more difficult to establish. Furthermore, where biologics are concerned, changes in manufacturing and scale-up can affect the overall approvals process. Centralisation of regulatory functions in Europe has also had a knock-on effect for FDA operations, as the push towards global harmonisation continues. How industry changes are affecting regulatory affairs recruitment opportunities Phu Huynh is Senior Recruitment Consultant at Hays and based in New York City. He specialises in the recruitment of mid-to-senior level professionals in regulatory affairs and highlights the increasing demand for new talent in this fast-moving environment. Phu points to the rise in biologics innovators and their particular need for effective Chemistry, Manufacturing and Controls (CMC) regulatory compliance strategy: “The area with the biggest staff turnover is Chemistry, Manufacturing and Controls (CMC). When the FDA rejects a drug application, it is typical for the reason to fall within this area. Companies are consistently in search of solid regulatory CMC professionals that they can add to and retain in their organisation.” He also comments on the shortage of advertising and promotional professionals in regulatory affairs. These are individuals who are highly commercially focused and help to establish the competitive edge for products in the marketplace, right from very first stage of creation of a biological therapeutic entity. Could a move to regulatory affairs be for you? There are many candidates in the recruitment market seeking to gain hands-on regulatory affairs experience. As a well-remunerated area at the heart of the company power structure, it is not uncommon to find those in quality assurance or clinical research attempting to transition into regulatory affairs positions. As the sector evolves, those in existing positions are increasingly trading operational responsibilities for greater experience in strategic roles â€" that is, developing regulatory strategies to increase the success of FDA applications. Be part of the conversation. Join our Life Sciences Industry Insights LinkedIn group to share your thoughts and stay up-to-date with the latest life sciences employment and recruitment news. Join the conversation