Common regulatory affairs interview questions

There are a number of interview questions you could be asked during the application for a regulatory affairs role, and the questions involved vary based on the specific role you are applying for. Here are a few of our top tips to help you succeed:

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To ensure that you are prepared and increase your chances of success, we recommend studying the job description. From this, you may be able to predict some of the types of questions that are likely to be asked at the interview. It is useful to match the job description against your CV.

Then, you can think about when and where you have been able to demonstrate the skills, characteristics and experience the interviewer is looking for, and identify the most important aspects of the role. If you need help with your CV, find our advice here.

Some questions you could be asked during your interview include:

  • It is likely that you will be asked about occasions when you have dealt with regulatory authorities or agencies. Your answer should be specific here, you can add which agencies you have had experience working with based on your region – such as MHRA (UK), EMA (Europe) or the FDA (USA). Likewise, consider the different types of applications submitted to the UK/EU health authorities.
  • If the position you are applying for is European based, you may be asked about the experience you have working with European submissions and procedures.
  • A large part of regulatory affairs work today is electronic submissions, therefore you should be prepared to discuss what you know about this and your experience to date.
  • You are highly likely to be asked about the types of products you have previously worked with, as registration procedures differ between small molecules, biologics and medical devices. To add to this, if the role you are applying for is aligned to a specific therapy area (which should be clear within the job description), it may be essential to have worked with similar products or therapeutic areas. For example, if the role is focused on clinical trials, the employer will want to know which phases you have had experience working with. Therefore, you should expect questions about your relevant experience with these.
  • Communication skills are important, especially at senior levels and within companies that operate on a global level. You will likely be interacting with cross-functional, international teams so you may be asked competency-based questions around communication, such as the impact you have been able to previously make in a team environment or even asked to prepare a presentation.
  • Reflect on any difficult or high-pressure situations you have been involved in, and consider how you were able to deal with them as well as what you have learned as a result. You can use these examples in an interview to showcase how you will be able to overcome future situations.

Top tip: When answering any interview that asks for evidence or a scenario then always use the STAR technique to help you answer effectively:

STAR interview technique infographic

Take a look at more advice here