Responsibilities, day to day activities, position specific questions
Regulatory Manager Interview Questions
481 regulatory manager interview questions shared by candidates
Q: Have you used a DiGA or medical device app before?
What did I think about this role Describe something I could improve on Describe a situation where I had to deal with conflict As I was a cross-borderer, whether or not I was open to commute daily Did I have any other ongoing processes
Why do you want to join Sarepta Name a time you bought about change in the workplace How do your skills fit this role we are hiring for
Function specific discussions, open ended rather than closed/ overly prescribed, focussing on how you plan to deliver in the role you’re interviewing for. Tell me something weird about you.
Tell us a time that you failed to meet the task requirement and what you did to rectify the issue.
Standard behavioral questions about how I’ve addressed problems
Questions where generally geared to how I would react in specific situations (STAR).
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?
Asked me to describe my current role and what I was looking for in my next role.
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