All STAR format questions with 2 people.
Regulatory Coordinator Interview Questions
2,754 regulatory coordinator interview questions shared by candidates
what are your goals, have you worked on submittng protocols to irb etce
Why would you like to work at Baylis?
Why you want to change company
Everything was pretty straight forward. No tricky questions
introduce yourself, give me an example of, why do you want to work for us
Questions where generally geared to how I would react in specific situations (STAR).
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?
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