The document discusses the need for regulatory affairs professionals in the biotechnology industry. It explains that biotechnology uses techniques like cell culture and recombinant DNA to develop new products for medicine, agriculture, and the environment. Regulatory affairs ensures biotechnology products meet regulations before commercial use through tasks like tracking legal changes, reviewing safety data, and interacting with agencies like the FDA. For new, complex biotechnology medicines and therapies, regulatory oversight is especially important given the high research costs and risks.