Regulatory Affairs

Regulatory Affairs refers to the discipline within the pharmaceutical, biotechnology, and medical device industries that is responsible for ensuring that products comply with all regulations and laws governing their development, manufacturing, and marketing. Professionals in this field engage with regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to facilitate product approvals and ensure compliance with established standards. This involves preparing and submitting detailed documents, known as regulatory submissions, which provide evidence of a product’s safety, efficacy, and quality.

Regulatory Affairs also encompasses monitoring and enforcing compliance with regulations throughout a product’s lifecycle, from early research and development through post-market surveillance. The goal of Regulatory Affairs is to secure timely access to safe and effective products for patients while ensuring that companies meet legal obligations. Additionally, it may involve advising organizations on regulatory strategies, changes in regulations, and post-market requirements.