What Is Regulatory Affairs (RA)? RA 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. RA 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. RA professionals are responsible for ensuring manufacturers’ compliance 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 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.
What’s the Job Outlook and Market Demand? As the RA discipline plays an integral role in medicine, global health, food safety, and medical innovation, it’s no surprise that the job market is growing. In 2016, the U.S. regulatory market experienced a 42 percent increase in job listings and the U.S. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until 2026. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase.
BUT WHAT DO THESE PROFESSIONALS ACTUALLY DO ON A DAILY BASIS? RA officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. RA specialists are expected to be extremely passionate regarding the safety and efficiency of drugs and medical devices in the health care industry. Their interest for the sector must be deeply grounded into their function. This role demands expertise in a few distinct areas to be able to become successful. The role includes gathering, evaluating, organizing, managing and collating information in a variety of formats/ ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA), different regulatory bodies such as the Food and Drug Administration (FDA or USFDA), Health Science Authority or HSA, the Singaporean regulatory agency, European Medicines Agency (EMA) etc.