The Regulatory Affairs department plays important role in ensuring that pharmaceutical products meet both national and international regulatory standards throughout their development, production, and marketing. Acting as a connection between pharmaceutical company and regulatory authorities, RA professionals oversee the approval process for drugs, medical devices, and healthcare products by managing the legal, scientific, and commercial aspects. Their work is essential for navigating the complexities of global regulations, ensuring that products are safe & effective. With the rapid growth of the pharmaceutical industry, particularly in emerging markets like India, the need for skilled Regulatory Affairs professionals has significantly increased. These experts are responsible for preparing and submitting detailed regulatory documents, overseeing post-marketing compliance, and ensuring ongoing adherence to regulatory standards throughout a product’s lifecycle. Beyond compliance, RA also plays a strategic role in guiding product development and helping companies adapt to evolving regulatory environments. This review highlights the vital contributions of regulatory affairs to public health, product innovation, and the global pharmaceutical market.