7 results for "regulatory affairs"

Regulatory affairs is a profession in business that deals with compliance with government regulations in the pharmaceutical industry and other sectors where such regulations are stricter and more prevalent. The scope of regulatory affairs reaches beyond the business of prescription drugs into all medical technology, veterinary products, nutritional supplements, and cosmetics industries. Government rules require products to undergo rigorous tests to ensure their safety and effectiveness, and that's where a regulatory affairs department goes to work. If you work in regulatory affairs, you're responsible for making sure that products pass the test at each stage of development. You also have to be certain that those products will do what the manufacturer claims that they do.‎

Regulatory affairs is an important field because ensuring that products meet certain standards is crucial for their success and the health and well-being of those using them. Compliance with government regulations aims to keep unsatisfactory drugs, devices, cosmetics, and supplements away from store shelves and also shields companies from litigation and other types of trouble. You use products every day that claim to have a certain benefit for you. What if any one of those products was harmful instead of beneficial to you, or what if it didn't perform as promised? Regulatory affairs seeks to prevent those scenarios from taking place by subjecting items like these through rigorous checks and balances so that they meet all government requirements before they appear on the market.‎

Regulatory affairs is a far more complex field than it appears on the surface, and online courses on Coursera can give you a better grasp of the intricacies of this field. Learn about the pharmaceutical development process and discover the international regulations that govern how a new prescription or other piece of medical technology enters the marketplace. You can gain an understanding of the concepts behind regulatory affairs as well as the practical applications of this field in the business world to start a new career or to move up in your current workplace.‎