Regulatory Affairs

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Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs 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.

The regulatory professional typically has a background relevant to the business in which they work, i.e., science, law, or engineering.

The Regulatory Affairs Professional Society and The Organisation for Professionals in Regulatory Affairs (TOPRA) both provide professional support for individuals working in regulatory affairs within the pharmaceutical/medical device industry.

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