Regulatory affairs: A promising career option for researchers in biomedical science

Author : Lu Huang

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Many people have heard of “regulatory affairs,” but do not know what exactly that means. In my understanding, regulatory affairs is a field where you write, review, edit and submit all kinds of documents required in the process of drug development and clinical trials. The ultimate purpose is to gain market approval of your medicinal products (drugs, biologics, medical device and combination products) by the authority agency (FDA in the US) and to remain in good standing post-approval.