Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am preparing for an upcoming interview with a regulatory manager, specifically for a regulatory submissions role. I am looking for someone who works in the regulatory field to help me in my interview prep so as to guide me with possible questions I may be asked from such a manager in regulatory submissions. Is there anyone in this forum who would be able to help me prepare for the interview or a group that may exist that I can join that specializes in preparing for various regulatory interviews?

Hi Anon,

You don't provide a great deal of background as to your prior experience, so I am guessing here.  You may well be asked to provide an example where you had to develop a non-traditional approach to achieve regulatory clearance/approval.  You may also be asked as to how you negotiated with a regulatory body to find a strategy acceptable to all.  This may be in the areas of biocompatibility, human factors assessment, design verification, or design validation.  Another topic may be in your ability to "push back" on a regulator's unreasonable or unnecessary request that is not supported by data required of competitive products.  Also, there may be questions as to how you work with internal customers, such as marketing, who may wish to make unsupported claims in promotional labeling.  In such cases, I have found that a good approach is 'you can't say X, but you can say Y'.

Regards,
James

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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
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Original Message:
Sent: 02-Mar-2021 06:43
From: Anonymous Member
Subject: Interview prep

This message was posted by a user wishing to remain anonymous

I am preparing for an upcoming interview with a regulatory manager, specifically for a regulatory submissions role. I am looking for someone who works in the regulatory field to help me in my interview prep so as to guide me with possible questions I may be asked from such a manager in regulatory submissions. Is there anyone in this forum who would be able to help me prepare for the interview or a group that may exist that I can join that specializes in preparing for various regulatory interviews?

This message was posted by a user wishing to remain anonymous

Since your question is specifically related to a submissions role, you should also learn some basic stuff regarding publishing of documents. If you dont have prior experience, my gut feeling says focus on hypothetical questions like, if you are not sure which module section does a certain report like bioavailability report goes? and how do you go about on finding the answer?.......read guidances related to which report goes where like clinical report, nonclinical study report or CMC section etc.......
Original Message:
Sent: 02-Mar-2021 06:43
From: Anonymous Member
Subject: Interview prep

This message was posted by a user wishing to remain anonymous

I am preparing for an upcoming interview with a regulatory manager, specifically for a regulatory submissions role. I am looking for someone who works in the regulatory field to help me in my interview prep so as to guide me with possible questions I may be asked from such a manager in regulatory submissions. Is there anyone in this forum who would be able to help me prepare for the interview or a group that may exist that I can join that specializes in preparing for various regulatory interviews?

This message was posted by a user wishing to remain anonymous

Assessment and questions for such a role generally revolve around understanding your prior experience and capability to work with a cross-functional team, time management, people management etc. The focus is more on the soft skills than technical content as they have SMEs generating content for regulatory documents. They would also be interested in understanding whether you can gauge interdependencies across situations and work to adapt (submission) plans accordingly and your capability around problem solving.
Original Message:
Sent: 02-Mar-2021 06:43
From: Anonymous Member
Subject: Interview prep

This message was posted by a user wishing to remain anonymous

I am preparing for an upcoming interview with a regulatory manager, specifically for a regulatory submissions role. I am looking for someone who works in the regulatory field to help me in my interview prep so as to guide me with possible questions I may be asked from such a manager in regulatory submissions. Is there anyone in this forum who would be able to help me prepare for the interview or a group that may exist that I can join that specializes in preparing for various regulatory interviews?