Regulatory Affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory Affairs department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. Regulatory Affairs professionals are responsible for ensuring that manufacturers comply with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.

These regulatory affairs professionals play a critical role in the development and distribution of medical technological advancements and drugs, disease-free food, improving people’s health and welfare around the world.

It is not surprising that the employment market is growing as regulatory work plays an important role in healthcare, global health, food safety and healthcare innovation. In 2016, the U.S. regulated market experienced a 42% increase in job listings, and the US Bureau of Labor Statistics estimates that by 2026 this sector will continue to grow at an average rate of 8%. Expertise on additional professional regulations increases.

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