Regulatory Affairs-Interview Questions & Answers

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 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.

4.What is an Investigational New Drug (IND) application?

Ans- It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA

5.What is a New Drug Application?

Ans- The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA

In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”

6.What is an Abbreviated New Drug Application (ANDA)?

Ans- It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.

In simple words, “It is an application for the approval of Generic Drugs “

7.What is a Generic Drug Product?

Ans- A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. 

8.What is a DMF?

Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.