31 Regulatory Affairs Interview Questions (With Answers)

By Indeed Editorial Team

Published 31 May 2022

The Indeed Editorial Team comprises a diverse and talented team of writers, researchers and subject matter experts equipped with Indeed's data and insights to deliver useful tips to help guide your career journey.

Regulatory affairs is a highly specialised and niche industry that helps to protect the interests of companies that operate in industries that the government regulates. If you're looking for a job in a regulatory affairs role, you're likely to encounter a variety of different interview questions as part of the hiring process. Getting familiar with these questions and understanding how to answer them can help you increase your chances of getting a job offer for your desired role. In this article, we examine what regulatory affairs interview questions are and provide a list of 31 common questions.

What are regulatory affairs interview questions?

Regulatory affairs interview questions are questions that potential employers and hiring managers often ask candidates in an interview for a regulatory affairs role. Regulatory affairs professionals specialise in ensuring that companies in government-regulated industries comply with all the relevant rules and regulations that apply to their industry. They play an important role in ensuring that their employers don't experience government sanctions as a result of flouting any regulations. They may advise their companies on the appropriate measures to take when designing new products and may also conduct checks on the company's production processes to ensure that they comply with regulations.

11 general regulatory affairs interview questions

Potential employers and hiring managers often ask general interview questions to find out more about a candidate's personality and characteristics. Your answers to these questions can affect an employer's impression of you as a regulatory affairs professional. Making a good impression can increase your chances of getting a job offer. Here are 11 general questions that you can prepare an answer to before your regulatory affairs interview:

  1. Tell me about yourself.

  2. What's your educational background?

  3. What skills are you developing to help you in this role?

  4. Why are you applying for a job in regulatory affairs?

  5. Tell me about a time when you took initiative in a position.

  6. Do you prefer to work independently or in a team?

  7. How do you approach conflict in the workplace?

  8. What are your hobbies?

  9. How do you cope with stress from your job?

  10. What's a skill that you want to improve upon?

  11. Do you have any questions about the roles and responsibilities of the position you applied for?

Related: 5 Types of Interview Questions (With Sample Answers)

11 questions about regulatory affairs background and experience

Another factor that many potential employers and hiring managers consider when choosing a candidate to hire is the background and experience of the candidate. They may ask questions about your regulatory affairs background and experience to estimate your level of familiarity and proficiency with regulatory affairs matters. Here are 11 such questions that you can consider preparing for:

  1. What experience do you have in a regulatory affairs role?

  2. Share your experiences in collaborating with professionals outside of your industry.

  3. Provide an example of when you performed research to further understand a topic.

  4. What techniques do you use when researching a topic you're unfamiliar with?

  5. Describe a project you worked on that required collaboration.

  6. Discuss a time when you've had to use analytical skills to draw conclusions.

  7. What experience do you have with product labelling?

  8. Tell about a time that you made a mistake. How did you resolve it?

  9. What advice would you provide to entry-level regulatory affairs professionals, based on your experience?

  10. When did you realise that you want to pursue a career in regulatory affairs?

  11. Do you have any educational or other certifications that may help you perform the duties of a regulatory affairs professional?

Related: 10 Tips for What to Do Before an Interview (With Importance)

6 in-depth regulatory affairs questions

Lastly, an interviewer may also ask you in-depth questions about the technical aspects of regulatory affairs. These questions test your knowledge about regulatory affairs and answering them clearly and correctly can help you increase your chances of getting a job offer. Here are six in-depth questions that you may encounter in an interview:

  1. What's your biggest challenge regarding regulatory affairs processes?

  2. What's your experience with regulatory compliance issues?

  3. What differentiates you from other regulatory affairs professionals?

  4. How do you handle working with large amounts of data and research?

  5. What interpersonal skills can you use to help you perform the job successfully?

  6. Why is communication important between a government-regulated industry and the drug regulatory authorities?

Related: How to Tell if a Job Interview Went Well (12 Positive Signs)

3 regulatory affairs interview questions with sample answers

Understanding the objective of an interviewer when they ask a question can help you provide a more targeted answer that addresses their concerns. Here are three common questions that an interviewer may ask at a regulatory affairs interview, with an explanation of how to approach each one and sample answers:

1. What are your goals as a regulatory affairs professional?

Hiring managers may want to understand your professional goals in regulatory affairs. This question allows them to gain insight into your objectives and understand why you're pursuing a career in regulatory affairs. In your answer, include various goals that you want to achieve. These goals may be short-term goals, such as registering five drug products within one year. They can also be long-term goals, like improving pharmaceutical safety requirements to reduce medication symptoms by 50% in patients.

Example: 'My goals as a regulatory affairs professional include ensuring the safety and quality of drug products and advising pharmaceutical companies on common regulatory guidelines. Both of these goals allow me to provide help to patients and pharmaceutical professionals, which is one reason why I've decided to pursue a career in regulatory affairs. I also have several short-term goals, which include creating an innovative drug processing procedure that allows for a quicker approval time, and contributing to regulatory compliance research to determine areas of improvement for drug regulatory authorities.'

Related: What Does a Compliance Manager Do? (With Skills and Steps)

2. How do you measure success in regulatory affairs?

Interviewers may ask this question to find out more about your personal metrics for gauging your success at work. Your answer can provide them with a lot of information about your working style and may help them in deciding whether or not you'd be a good fit for their regulatory affairs team. While there are many metrics available, you can focus on talking about just one or two metrics. Explain in detail how you can use your chosen metrics to measure the success of a product that you're trying to launch or an operational change you're trying to make.

Example: 'Personally, I prefer to measure success in regulatory affairs using the timeliness and quality of my team's submissions to regulatory bodies. I firmly believe that when these two metrics are used together, they enable me to gain a clearer picture of how well my regulatory affairs team is performing. The timeliness of submissions enables me to estimate the efficiency of my team and whether or not we're able to manage the workload. The quality of submissions also enables me to see how well my team is performing and this can help me identify areas for improvement.'

Related: How to Sell Yourself in an Interview (With Interview Tips)

3. When was a time that you encountered conflict with a colleague and what steps did you take to resolve it?

Regulatory affairs specialists often work with professionals in various departments and industries, like pharmaceuticals, health care and government agencies. A potential employer may want to know how you resolve conflict to better understand your teamwork abilities. In your answer, provide details about a story that involves conflict, identify the problem and list the steps that you took to fix the issue.

Example: 'While working in a pharmacy, I disagreed with a colleague on how to label a medication. My colleague wanted to continue using the old labelling process while I believed we should label the products using a newer product labelling process. To better understand their perspective, I asked them why they felt that the old version worked better than the new version. After having several discussions about our viewpoint, we found a compromise and used a mixture of the old and new labelling processes. This experience taught me that successful conflict resolution involves having open discussions and finding a compromise.'

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