Questions where generally geared to how I would react in specific situations (STAR).
Regulatory Coordinator Interview Questions
3,380 regulatory coordinator interview questions shared by candidates
There are a lot of office politics that could happen, if someone gave you work that should not be yours, what would you do?
Tell me about yourself, your experience, why are you looking to change jobs, expected salary...
1) Difference between reprocessing and reworking 2) Filing mechanism for manufacturing scale change 3) Heat Penetration Study for validation of depyrogenation tunnel 4) Define starting material 5) Do you know the ICH quality guidance documents? 6) Name the guidance documents that govern cGMP 7) Examples of process and product related impurities 8) Specific in vitro tests to determine the toxicological effects of product related impurities 9) Are you familiar with FDA's guidance on bispecific antibody development? 10) Hypothetical case - Assume that we have a product on the market with an established 24 month expiry period. During one of the ongoing stability studies, product degradation is observed at a 12 month time. What will be your approach to address this issue from a regulatory standpoint?
Difficult situation you faced in life and how you managed
Typical job specific interview questions like explain how you have handled a difficult situation
Experience and further suggestions for development
1. Regulatory timelines 2. Regulatory authorities 3. Dechallenge and rechallenge 4. Difference between adverse event and adverse drug reaction 5. Korean guidelines for submission
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