If you are attending a regulatory affairs interview, you cannot miss these interview questions in your preparation list, before attending the interview checking the previously asked questions is very crucial, because the interviewer is going to test your knowledge in the regulatory domain, and tests your problem-solving skills and also your communication skills. 

Here are the most frequently asked interview questions in regulatory affairs

1. Explain about regulatory affairs in the pharmaceutical industry.

Answer:  The regulatory affairs department acts as a liaison between the Govt regulatory authorities and our organization, which involves ensuring compliance with the regulatory guidelines that govern the development, manufacturing, and marketing of pharmaceutical products.             The regulatory affairs department is responsible for ensuring that the products we make are safe, effective, and of high quality protecting public health.

2. Why do you want to join the regulatory affairs department?

Answer: This is a compulsory question, and you must answer this question by sharing your interest in the domain, you can say like I want to pursue regulatory affairs as a career as I always wanted to ensure safe, effective, and quality medicines are available to the public. what made you choose this domain you must say clearly without any self-doubt.

3. Mention some regulatory authorities you know?

Answer : You can give three to four regulatory authorities names like

1. United States: Food and Drug Administration (FDA)
2. European Union: European Medicines Agency (EMA)
3. United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA)
4. Canada: Health Canada
5. Australia: Therapeutic Goods Administration (TGA)
6. Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
7. China: National Medical Products Administration (NMPA)
8. India: Central Drugs Standard Control Organization (CDSCO)
9. Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
10. South Africa: South African Health Products Regulatory Authority (SAHPRA)

4.  Mention the modules present in Common Technical Document?
Answer: Module 1: Administrative information – region specific
Module 2: Quality Overall Summary
Module 3: Quality
Module 4: Non -Clinical Study Reports
Module 5: Clinical Study Reports

5. What is a dossier

Answer: A dossier is a document containing technical information regarding the newly developed product for submission to regulatory authorities to get marketing authorization or license. A dossier contains information regarding the quality, safety and efficacy of the newly developed product.

6. What is a Drug Master File ?

Answer : It is a submission to regulatory authorities containing confidential information regarding the Chemistry Manufacturing and Controls of a drug product and it is submitted as supporting document to IND , NDA or ANDA and its not a substitute for them , and a DMF is reviewed only when it is referenced in an application or another DMF.

7. What is Investigational New Drug Application

Answer:  An IND is an application submitted to FDA  , when the sponsor wants to test new drug in humans once acceptable results are found in preclinical studies , Once the IND is accepted the sponsor can proceed for clinical trails in humans. IND contains information regarding the chemistry , manufacturing and preclinical studies and also about proposed clinical trails protocol.