Regulatory Affairs-Interview Questions & Answers
Regulatory Affairs-Interview Questions & Answers August 21, 2019 1. What is Regulatory Affairs? Ans- 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. 2. What are the goals of Regulatory Affairs Professionals? Ans- Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information 3. What are the Roles of Regulatory Affairs professionals? Ans- 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 expe...