Regulatory Affairs Interview Questions

Top 20 Regulatory Affairs Interview Questions Asked in MNCs in Hyderabad

These are the Top 20 Regulatory Affairs Interview Questions Asked in MNCs in Hyderabad. Our real time experienced trainers are working in Top MNCs in Hyderabad, most of the times, they only take interviews and they shared that these are the top 20 interview questions asked in Regulatory Affairs interview.

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1. What do you mean by Regulatory Affairs and what are the roles of RA profession?
2. Importance of stability studies and extrapolation conditions?
3.  What do you mean by bracketing and matrixing stability studies?
4.  What are the examples of significant change during stability studies?
5.  Types of impurities and how limit for each impurity will be assigned?
6.  what do you mean by genotoxic impurities and what is the limit for it?
7.  what do you mean by 4-tier specification and importance of each of them?
8. what are the factors affecting dissolution studies, there limits and acceptance criteria?
9. what is generic drug and how its equivalent to innovator drug?
10. Define the term validation and explain different types of validation?
11. what do you mean by bio-equivalence studies and its acceptance criteria?
12. How many types of DMFs and Patent filing exist in the US?
13. How many types of drug approval procedures are there in EU filling, narrate DCP and MRP timetable?
14. Explain GDUFA, RTR, orange book and drug approval procedure in the US?
15.what do you mean by CTD and how many modules are present in CTD?
16.what are different post-approval types in US and EU?
17.what do you mean by CEP and how its different from ASMF?
18. Explain the terms EDQM, EMA,TGA, IND,NDA, ANDA & MAH?
19.what do you mean by data exclusivity and marketing exclusivity?
20. what do you mean by Para-IV filing in the US?

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