Regulatory Affairs & its Role in Pharmaceutical


What is Regulatory Affairs

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

Goals of Regulatory Affairs

  • Protection of human health
  • Ensuring safety, efficacy and quality of drugs
  • Ensuring appropriateness and accuracy of product information


Role of Regulatory Affair

  • Act as a liaison with regulatory agencies
  • Preparation of organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions
  • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws
  • Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans
  • Advising the companies on regulatory aspects and climate that would affect their proposed activities
  • Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.