Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:
- Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
- Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
- Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
Read more about Regulatory Affairs: Healthcare RA
Famous quotes containing the word affairs:
“Winter lies too long in country towns; hangs on until it is stale and shabby, old and sullen. On the farm the weather was the great fact, and men’s affairs went on underneath it, as the streams creep under the ice. But in Black Hawk the scene of human life was spread out shrunken and pinched, frozen down to the bare stalk.”
—Willa Cather (1873–1947)