Enhancing Risk Management by Listening to Your Employees: Ensuring That “Smoke” Does Not Lead to a Regrettable Inferno

| 01 November 2008

The role of the regulatory professional has changed. More is expected than delivering regulatory advice when it is requested. Whether in a large corporation or a mid-sized or small organization, the US regulatory professional continues, of course, to perform the traditional role of answering questions about the legal and regulatory requirements associated with product approvals, Good Manufacturing Practices, advertising and promotional materials, and responses to inspections by the Food and Drug Administration (FDA). But the job today entails more. Good regulatory professionals in companies regulated by FDA guide their colleagues to stay within the letter of the law and the bounds of propriety when performing their employment responsibilities. The best of the class go further and actively work to ensure that business risks and perils that may damage a company's reputation are kept within manageable limits. In this regard, the regulatory affairs department frequently is the first line of contact with employees who raise questions about company activities that may violate the law. These employees may have legitimate concerns or may have an axe to grind, but all such inquiries must be addressed in a timely and effective manner.


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