Ten Steps: How to Prepare for a Regulatory Job Interview

Ten Steps: How to Prepare for a Regulatory Job Interview

Ten steps: How to prepare for a regulatory job interview

By Brandan Sweeney

Key Words: Clinical Operations, Clinical Research, Regulatory Affairs, Preclinical, Discovery, Medical Information, Drug Safety, Medical Writing, Data Management, Auditor, Biostatistics, Manufacturing, Project Management, Program Management, Medical Science Liaison, Marketing, Business Development, Commercial, Outsourcing, Analytical, Biology, Research and Development, Product Development, Toxicology, Pharmacology, Medical Affairs, Pharmaceutical Development, CMC, Quality Assurance, Quality Control, Medical Director, Director, Vice President, CMO, CRO, ARO, Pharmaceutical, Biotechnology, Medical Device, Diagnostic, Generics, Life Sciences, Executive Search, Recruiting, Recruiters, Recruiter, Venture Capital

Job Interviews are stressful, especially if you don’t spend the time it takes for a successful end-result.  In the past, the preparation for an interview was all the same, no matter the industry or specialty you worked in.

When it comes to the regulatory affairs interview, this is a very specific interview preparation; one which requires strategic planning and preparation.

Whether you are looking to move ahead in title and responsibilities, changing companies, becoming an independent consultant, or transitioning to a new specialty of regulatory affairs, I’ve created the top ten tips which help prepare you to succeed at your next Regulatory Affairs job interview.


If they haven’t done so already, the recruiter should have provided you with the following:

  • The type of interview you’ll be having (e.g. panel, group, individual)
  • The name of your interviewer(s)
  • Company culture
  • Personalities of the interviewers
  • The top 5% of salaries according to the level and geographic location
  • Previous success stories from other candidates
  • If this information hasn’t already been provided, ask for it! It is in the recruiters best interest to succeed just as much as yours. Remember, your success in an interview begins and ends with preparation!
  1. RESEARCH THE COMPANY YOURSELF (in addition with the recruiter)

Despite our advice about utilizing the services of a recruiter, it is still your responsibility to research your potential new employer. As the old adage goes, ‘failure to plan, is planning to fail’.

The research will help you answer critical questions such as:

  • What products/services is the company most recognized for?
  • What differentiates the company from others in the same marketplace?
  • What is the value and mission statement of the company?
  • What are the company goals within the next 3 years and how does this position (you are interviewing for) play a role in the achievement of these goals?
  • Does the company appear to have a culture that embraces intellectual curiosity?
  • Has the company been recognized with any external rankings or awards as a great place to work?

The following sources will provide valuable information on your new potential employer:

Company Website – To learn about the company’s values, its mission statement, products/services, and management team, as well as further information from the Press Release or Media section to find out where the company is heading.

Regulatory Agency Websites (e.g. EMA/FDA/PDMA) – To search for  information regarding the company’s products that may not be on their website. An example will be the public assessment report of a recent product approval, or the current product information documents. A review of the agency websites will help you answer the following questions :

  • What are the company’s major products?
  • What are the company’s specialities (e.g. clinical trials, rare diseases, Advanced Therapy Medicinal Products (ATMPs), generics, biosimilars etc)?
  • Has the company recently received any major new drug approvals in any region (EU, Japan or USA)?
  • Are there safety issues the company is currently trying to address?
  • Are there new guidelines coming into effect which will impact the company?

LinkedIn – To identify additional information not on the company website. You will find LinkedIn a useful source of information on new employees, promotions, jobs posted, related companies, and company statistics, which may not be on the website. LinkedIn is also useful for finding members of your network who work/worked at your potential employer, and it will also help with your research into your interviewer(s).

Social Media (e.g. Twitter/Google+/Facebook/Glassdoor.com) – To get an idea of how the company is perceived (i.e. does the company embrace Social Media and wants to be (“hip”?). There may also be information on these platforms that’s not on the website. Make sure you “follow” the company to get regular updates.

Google – To find out what the media are saying about your potential employer. You will find the ‘News’ feature a useful source of information on the latest article, blogs, or newspaper articles about the company. A google search can also dig up other useful information such as stock prices, potential mergers, and deals with other pharmaceutical companies.


Do not underestimate the power of your network when it comes to preparing for an interview. Nowadays, LinkedIn is the main source for most people when it comes to professional networking and should be utilized as much as possible to better understand the company you plan to interview for, and the type of people working there. Consider reaching out to people within your network that work, or have worked at your potential employer, for advice or information on what it is like to work there. Remember to be respectful and professional; do not chase responses to your request as over-persistence can irritate people.


The job description is very useful way to prepare for the type of interview questions you may receive. Put yourself in the shoes of the interviewer and develop a list of potential interview questions based on the list of required and preferred skills in the job description.

If the job description for the role is limited and leaves you uncertain about what to expect at the interview, work with your recruiter to identify the required and preferred skills. Ideally your knowledge and experience should be a good fit for the role, but this isn’t always the case.

Many people have experienced situations where the job description doesn’t fully match your knowledge and experience. If you find yourself in this situation, draw up a separate list where you feel there are gaps in your skills or knowledge. Work through potential answers to questions regarding these gaps, drawing upon other work or life experiences and skills to show your potential employer your willingness to adapt and to learn.


During an interview you’ll often be asked questions about your experience in specific areas, such as, “how much experience do you have with preparing and submitting an MAA in the EU for an orphan designation?”.

Rather than just considering a straight forward answer with figures, you should consider the benefit (or value-added) your experience in these areas could bring to your potential employer. So rather than just saying “I’ve been involved in a number of applications for various orphan applications via EU” you might consider something like, “although I’ve been involved in many orphan applications, there have been a couple that really tested me, where I was required to work closely with the Clinical/Safety/CMC colleagues to respond to some really challenging questions. I feel my experiences from these procedures will prove really useful in this role at your organization”. This type of response will hopefully prompt further questions from the interviewer, and result in an engaging conversation during the interview. Focusing on how your experience can benefit your employer will help to differentiate you from the other candidates.

  1. PREPARE INTERVIEW STORIES (The E-IQ side of you!)

Most job interviews now include behavioral questions, as it is believed that your past behavior is a good indication of your future behavior. Examples of such questions typically begin with “Tell me about a time when…?”, or “Give me an example of when…?”.

These days employers care more about how you act under pressure, vs your level of intelligence. Build a story using examples from your experience. The methods commonly used to answer behavioral interview questions are PAR, SAR or STAR (further details on these can be found here). The example below uses the SAR method (Situation, Action, Result) to answer the following behavioral question, “Tell me about a challenging situation and how you overcame it”:

Situation: I was managing a DCP for a new generic license which was important for the company. Although the RMS and most of the CMS’s were happy to finalize the procedure, one country (France) remained unhappy with the bioequivalence (BE) study.

Action: The license was critical to the business, so based on my previous experiences of dealing with difficult countries, I recommended to my clinical, safety, and CMC colleagues for a post-marketing commitment to conduct a new study to ensure the filing is concluded.    I was able to align the company’s developments to ensure all key colleagues agreed with the approach. We presented this to the agencies, who also agreed with our proposal which led to a successful filing.

Result: After a few telephone calls, EMA eventually agreed with our proposal and the filing was completed.

Use your preferred method (PAR, SAR, or STAR) to develop several of these relevant interview stories based on your experiences and the job description. This will help you answer questions in an articulate and cohesive manner whilst also staying on-topic.


There are plenty of online resources with thousands of interview questions and examples (e.g. glassdoor.com), Indeed, etc). It is likely the first part of the interview will focus on your resume. However, a major part of the interview will most likely focus on your suitability for the organization, and may involve behavioral questions around time management skills, negotiation skills, or your ability to work under pressure.

Potential questions for a Regulatory Affairs role may focus on your experiences in:

  • How to work successfully with regulatory agencies
  • Different licensing procedures (e.g. EU CP, MRP/DCP, and National or US NDA and BLA)
  • Current regulations and guidelines
  • Navigating the various eCTD sections
  • Working with a global team across different time zones (e.g. USA, Japan)
  • Developing regulatory strategies for submissions in different regions
  • Working with different regulatory document management systems/IT software
  • Regulatory intelligence and understanding of the current regulatory environment

Personal or behavioral questions you may be asked during the interview include:

  • Tell me about yourself
  • Why do you want to work at our company?
  • What is your greatest weakness?
  • Tell me about a time when you made a mistake? How did you handle it?
  • Tell me about how you worked effectively under pressure?
  • Why are you leaving your current position?
  • What makes you think you are a good Regulatory Affairs professional?
  • What area of Regulatory Affairs most interests you?
  • Tell me about a major accomplishment.
  • What are your long-term career goals?
  • When was the last time you thought “outside the box” and how did you do it?
  • Why should we hire you over other candidates?

According to a study from the Journal of Occupational and Organizational Psychology, 60% of hiring decision were made within the first 15 minutes!!! The study also showed that the “small talk” portion of an interview can be just as important as the seemingly tougher job-related questions. With this in mind, it’s important to make the interview more of a conversation, rather than a Q&A session.


A person’s body language and tone of voice are what we as humans mainly use to assess whether we like or “click” with a person. Follow the tips below to help you produce the correct body language and allow your responses to seem relaxed and natural during the interview:

Posture – From the waiting area to the interview room, maintain good posture while either standing or sitting. It’s natural for people to slouch and make themselves smaller.  Being aware of your posture throughout will help you project an air of confidence.

Handshake – Studies support handshakes play an important role in making a positive impression. The handshake is most likely your only moment of physical contact with the interviewer(s). Your handshake shouldn’t be too firm or too soft.

Arms and legs – Avoid crossing your arms and legs. According to most psychologists, crossing your arms is a defensive habit which can be a sign of nervousness. Additionally, crossing your legs could lead to fidgeting during the interview – another sign of nervousness.

Use Your Hands – Do you naturally talk with your hands? Go ahead and let them move during the interview. Stopping the natural gestures may lead to an awkward appearance. Just make sure your motions don’t become so enthusiastic that they distract from your words.

Eye Contact – It’s important to make eye contact during your interview, but don’t mistake that for a directive to make constant eye contact. That is disconcerting and aggressive. Think: How would I make eye contact if I were chatting with a friend? For panel interviews make sure you make eye contact with all interview members, while ensuring you focus on the person asking the question.


The final part of an interview usually provides candidates with the opportunity to ask questions about their potential employer. An interview is a reciprocal situation – your potential employer will be asking questions to learn about you and your skills, while you should also be determining whether the job is right for you.

Here are some questions you should consider asking:

  • What do you like best about working for this company?
  • Describe the culture of the company.
  • Where do you think the company is headed in the next 5 years?
  • Can you tell me more about the day-to-day responsibilities of this job?
  • If I was given this position, what is the most likely first assignment that I can expect to be given during the first month?
  • How will my performance be measured?
  • What on-the-job training or workshops will I be able to attend?
  • Can you explain how I will have input into my schedule and the projects I will work on?
  • What are the biggest challenges facing the company/Regulatory Affairs department right now?
  • How do I compare with the other candidates you’ve interviewed for this role?
  • What are the next steps in the interview process?


Asking well-thought out questions which convey your level of preparation and goes a long way to making a positive impression. It is important that your questions are a genuine attempt to address any concerns you may have about the job role.

*Always avoid asking questions that could be answered from the company’s corporate website.


To save you from sitting nervously by the phone awaiting feedback, make sure you ask about the decision-making process during the interview. This will help manage your expectations and avoid the situation where you end up worrying about the outcome of the interview without being aware that the interview process timeline.

Remember to ALWAYS write thank you notes to each person who interviewed with you, usually within two business days. You will be surprised just how many people do not do this. More times, than not, this approach pays huge dividends to the over-all decision.  It shows your level of seriousness and interest in the opportunity.  Remember to make sure each thank you note is personalized.  Cut and paste, is not advisable since most interview attendees will share your “thank you) note amongst themselves.

Be sincere with the thank you note. It shows character and an appreciation for the employer’s time and interest in you. It also serves to remind the employer that you are committed and genuine. It is also be helpful in bringing you back to the top of the interviewer’s mental list, particularly if they have interviewed several candidates for the role.

Finally, remember to contact any professional references you wish to use should you receive an offer. The time it can take to contact them, find out their availability, can take up to 2 weeks.  This can significantly delay the decision-making process and it shows you lack preparation.  Instead, you should approach your references to let them know their services may be required in the near future. The sooner they know, the quicker they’ll react when communication is made.

Don’t forget to be yourself!  Good Luck!

Learn more about our Regulatory Affairs practice area and reach out to our Regulatory Affairs practice area leader, James Calvino. 

We have several interview preparation documents available here. 

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