ABSTRACT

Regulatory affairs professionals can be found in all sorts of companies, for example, biotech, pharmaceuticals, medical devices, diagnostics, and even nutritional products. They play critical roles in the health product lifecycle, from development through post-market approval. The regulatory affairs professional must also be able to capture intelligence from a variety of sources. This should translate to the ability of critical thinking as well, as one is able to anticipate the changes in the external environment and disseminate internally to the organization as a value-add. An all-rounder is often required to understand science, business, and government language and procedures. A person who wishes to shape healthcare decisions and policy, with the belief that the work Regulatory professionals are doing is to help people, many of whom have life-threatening diseases, should consider entering the profession. It is crucial for regulatory affairs professional to be adaptive and believe in continuous learning.