What is Regulatory Affairs?
Regulatory Affairs (RA) is a scientific and technical discipline ensuring a company meets all of the regulations pertaining to its industry. It is a complementary role to that provided by the legal department. RA professionals in cosmetic, food, nutritional supplement, drug and medical device companies will usually be scientists or physicians who can deal with the complex regulatory aspects of their products. They typically are the front-line contact with regulators such as Health Canada and the US FDA.
Regulatory Affairs can become involved in a project as early as product development, manufacturing, and clinical trials, and can be involved with labeling and claim compliance. RA is sometimes defined as the “middleman” between the company and the government regulatory agency.
The goal of regulatory affairs professionals is to protect the environment and human health, to ensure products meet regulations on quality, efficacy, and safety, and to ensure product information is accurate and compliant.