A Review on Drug Regulatory Affairs in Pharma...

A Review on Drug Regulatory Affairs in Pharmaceutical Industry

Author Name : Snehal Bhand, Aher Manjusha, Kiran Shinde, Vishal Tekude, Rutuja Chavan, Bhushan Khajindar

ABSTRACT Regulatory affairs are an emerging profession focused on ensuring the safety, quality, and efficacy of drug products. This is achieved by submitting Investigational New Drug (IND) applications and New Drug Applications (NDA) to the relevant regulatory authorities for approval. The role of regulatory affairs is to develop and implement a regulatory strategy that ensures the drug development team’s efforts lead to the approval of products by global regulatory authorities. It offers diverse career opportunities for graduates with a scientific background who excel in communication, teamwork, multitasking, and have a strong desire to expand their knowledge in the pharmaceutical industry. This project focuses on the history, regulatory policies, administration, and related issues across various countries, including India, Japan, China, Europe, the US, Australia, Brazil, and Canada. It is also responsible for ensuring the accuracy and relevance of the product information. Regulatory Affairs offers an appealing career path for graduates with a scientific background who thrive on communication and teamwork, are adept at multitasking, and are eager to deepen their knowledge within the expansive field of pharmaceuticals.