General questions

The following list includes general questions that you may encounter during a
regulatory affairs interview that relate to your personal and professional life:

 Tell me about yourself.

 What is your educational background?
 What skills are you developing to help you in this role?
 Where are you from?
 Tell me about a time when you took initiative in a position.
 Do you prefer to work independently or in a team?
 How do you approach conflict?
 What are your hobbies?
 Do you have any coping mechanisms to handle stress?
 What is a skill that you want to improve upon?
 What is your greatest strength?

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Questions about experience and background

Employers may be more likely to hire candidates that provide detailed
information about their qualifications. Here are some questions to help hiring
managers understand your background and experience in regulatory affairs:

 What is your experience in the pharmaceutical industry?

 Share your experiences in collaborating with professionals
outside of your industry.
 Provide an example of when you performed research to further
understand a topic.
 What techniques do you use when researching a topic you're
unfamiliar with?
 Describe a project you worked on that required collaboration.
 Discuss a time when you've had to use analytical skills to draw
conclusions.
 What experience do you have with product labeling?
 Tell about a time that you made a mistake. How did you resolve
it?
  What advice would you provide to entry-level regulatory affairs
professionals, based on your experience in the pharmaceutical
industry?
 When did you realize that you want to pursue a career in
regulatory affairs?
 Where did you attend college?

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In-depth questions
Here are several in-depth questions to give employers a deeper look into your
qualifications and skills that make you a valuable candidate:

 What is your biggest challenge regarding regulatory affairs

processes?
 What interests you about regulatory affairs?
 What is your experience with human health protection?
 What sets you apart from other regulatory affairs professionals?
 How will you interact with a team of pharmaceutical
professionals?
 How do you handle working with large amounts of data and
research?
 What interpersonal skills can you use to help you perform the job
successfully?
 How do you measure success in regulatory affairs?
 Why are you pursuing a career in regulatory affairs?
 Why is communication important between the pharmaceutical
industry and the drug regulatory authorities?

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Example regulatory affairs interview questions

with answers
Here are several examples of regulatory affairs interview questions with sample
answers:
How do you plan to remain up-to-date on new product and
industry advancements?

Having a career in regulatory affairs requires you to remain up-to-date on the

most recent pharmaceutical research, drug advancements and medications. In
your answer, provide actionable steps that you can take to keep track of recent
advancements. You may also include specific resources that you can use to
learn about new products.

Example: "To stay up-to-date on the most recent advancements in the

pharmaceutical industry, I plan to prioritize research and subscribe to various
pharmacy journals. This allows me to learn about innovations regularly so that I can
stay current on the newest products and drug registration. I also plan to
communicate with my colleagues about pharmaceutical advancements, so that I can
learn about new products that I may be unaware of."

What is your experience with the drug regulatory authorities?

This question gives hiring managers insight into your experience with drug
processing and regulations since the regulatory authorities act as a liaison
between the pharmaceutical industry and drug regulatory
authorities. Employers may want insight into your collaboration with drug
regulatory authorities to help them determine that you can perform your job
successfully. They may also want to measure your experience with the drug
regulatory authorities to establish your familiarity with their drug acceptance
policies and product processing.

Example: "Throughout my experience in the pharmaceutical industry, I

communicated with the drug regulatory authorities on various occasions. I feel that
it's important to have open communication between the pharmaceutical and the
drug regulatory authorities. Mainly, I contacted them to request further information
about the safety and quality of specific medications. They answered my questions
and encouraged me to contact them with any further questions or concerns."
Share your experience with new drug applications.

A large part of the duties for regulatory affairs professionals involve obtaining
legal approval for pharmaceutical materials using drug applications. Try
including details about your specific experiences with new drug applications to
demonstrate your knowledge of the application process. It may be useful to
include a specific example of a drug application that you filled out, or you may
share the estimated number of drug applications you've completed throughout
your experience in regulatory affairs.

Example: "While in my previous position, I filled out 5+ new drug applications per
week. To complete the application, I communicated with various pharmaceutical
companies to understand the drug's intended purposes and ingredients, and I also
communicated with the drug regulatory authority to determine their drug
specifications and requirements."

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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 to
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, like registering 5 drug products within one year, or they can 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 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."
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 the pharmaceutical industry, health care field
and government agencies. Hiring managers 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. I believed we should label the products using an innovative
product labeling process, while my colleague wanted to continue using the old
labeling 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 labeling process. This experience taught me that successful conflict
resolution involves having open discussions and finding compromise."