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Regulatory Affairs

Similar or Alternative Terms Meaning the Same Thing NA
Related Term(s) Medical Affairs, Medical-Legal-Review (MLR)

Definition

Regulatory affairs (medical 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).
  • 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.


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