INSIGHTS OF REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY – A REVIEW

Ashok Gorja*, Challa Deepika Reddy, Keerthi Sucharitha and Samperveni Tanmai

Regulatory affairs (RA) plays a vital role in the pharmaceutical industrial department which has the responsibility for obtaining approval for new products arriving in the market and ensuring that approval is maintained for as long as the company wants to keep the product for marketing & it also provides calculated and operational ways and assist for working within regulations to accelerate the development and delivery of safe and effective healthcare products for every particular person all over the world. It behaves as the link between the regulatory authority and the project team and is the passage for communication with the regulatory authority as it moves forward, the target is to ensure that the project plan correctly predicts what the regulatory authority will require before approving the product. The role of regulatory affairs is to develop and carry out a regulatory strategy to make sure that the collective efforts of the drug development team result in a product that is going to be approved by global regulators. Regulatory Affairs has many career choices for graduate students from a scientific background who are interested in communication and teamwork, are complacent with multi-tasking, and have enthusiastic responses to expand their knowledge in the pharmaceutical world. Regulatory Affairs is a gratifying, mentally invigorating, and highly considered profession within the pharmaceutical field.