The Regulatory Interview: Preparing for Success

The interview is one of the most significant steps of the job search process-understandably, it also can be one of the most stressful. Preparation is key. While resumes, experience, credentials and references are all important in regulatory, the face-to-face interview can be the final determining factor between go and no go. Therefore, it is imperative to make the most of your face-to-face meeting (even if via Skype or videoconferencing) to steer the odds in your favor.

At a recent industry meeting, I was afforded the unique opportunity to interview numerous candidates for only one opening in regulatory. Throughout this experience, I noted many factors for regulatory interviewees to consider. Also, from working closely with individuals relatively green in their regulatory careers, I have found the interview process is a topic of curiosity to many. This view from the other side of the table provides general tips on preparing for an interview as well as specifics for the dynamic and challenging regulatory profession.

Preparation

Know the Role

Whether applying for a regulatory position in product development, lifecycle management, operations or postmarketing product regulation, you should have a strong understanding of the job description. During the interview, present background, experience and skills that apply directly to what is specified in the job description. This may pose more of a challenge for those in entry-level positions, recent graduates and professionals transitioning into regulatory who may not have the relevant experience. If this is the case, display an understanding of the health product sector and some knowledge of the regulations. Even if you do not have the exact regulatory experience desired, you should share experiences and training that can be applied to the job. For example, provide specific examples and details on leadership skills you used on a project, in school or as a volunteer at a community service organization. Essentially, for every responsibility or skill described in the job description, be prepared to discuss applicable examples of your experience, whether in regulatory or elsewhere.

Know Your Interviewers and the Company

The Internet is an extremely handy tool. If possible, obtain the schedule of interviewers beforehand and search for information on each person. Try to get an understanding of their roles within the company and how they relate to the position for which you are interviewing. Research their areas of expertise, career paths and any papers published. The more you know, the better you will be able to relate to the interviewer, prompting reciprocal interest in you.

Before the regulatory interview, it also is a good idea to obtain an understanding of the company beyond its product line. Learn what is going on with the business, recent regulatory milestones, compounds in the pipeline and corporate structure. Researching the company's website can provide a wealth of information on its regulatory history and what future milestones are expected. Company-issued press releases, investor materials and other news can provide helpful insight into recent New Drug Application (NDA) filings or approvals, Complete Response Letters or Advisory Committee results. This research allows you to come prepared to the interview, and demonstrate an understanding of the company and the regulatory department. Then, take it a step further: describe what aspects of the company would allow you to accomplish your goals and help the organization succeed.

Know Your Resume Inside and Out

Make sure you know what your resume says about you and remember to bring a copy for each interviewer. Most importantly, know thyself. Interviewers are likely to pick out certain experiences or projects listed on a resume and ask specific and detailed questions to get a better understanding of your role and what you gained from that role. Be prepared to provide details, speak to leadership experience and describe your contribution to each item listed. While the resume is supposed to show off your accomplishments and achievements, there is a fine line between boastful and truthful. Make sure everything on the resume is truthful and can be validated by others upon reference check.

Know Your Skills

Certain skills are sought after, depending on the type of regulatory position. Negotiation skills and solution-oriented thinking are essential for a regulatory reviewer on promotional review committees. A regulatory strategist must be able to lead interdisciplinary teams and collaborate with partners in other functional areas. All interviewees should demonstrate their communication and organizational skills and ability to focus on details. Technical skills such as working with different types of systems and regulatory submissions also are an important requirement for many regulatory positions.

Gain the Experience and Apply it

If you do not have regulatory experience yet and are interested in building a regulatory education before applying for the job, options include certificate courses or master's degree programs offered at some universities. In addition, some regulatory organizations such as the Regulatory Affairs Professionals Society (www.raps.org) offer online courses, certificates in regulatory affairs for medical devices and/or pharmaceuticals and other resources such as reference textbooks, conferences and webcasts. If you are trying to break into regulatory from another department, spend time learning about the regulatory group within your organization, whether through a formal job rotation, one-on-ones or shadowing opportunities. Building your regulatory knowledge and experience not only prepares you for the sought-after position, but allows you to demonstrate initiative and interest and learn professional terminology to use with the interviewer.

If you have the relevant regulatory experience required for the job, speak to it. Provide specific details about the multiple projects you managed simultaneously, how you negotiated with regulatory agencies such as the US Food and Drug Administration (FDA) to achieve the desired outcome or the strategy you developed to achieve a faster timeline for the company. Apply examples from your own regulatory experience to demonstrate your knowledge, skills and fit for the position.

What to Expect During the Interview

Interview questions vary from company to company and from interviewer to interviewer, but there is common ground that will likely be covered. Be prepared to:

Demonstrate Ethics and Integrity

Regulatory professionals need high ethical standards and integrity in their daily activities, particularly when working with regulators. Not only are we working in a highly regulated industry, but our work product directly impacts patients' lives. Make sure strong ethics are evident in your interview responses.

Anticipate Behavioral/Situational Questions

Ah, the dreaded situational interview questions. You can identify them when the questions begin with "Tell me about a time when…" or "Can you give me an example of…" etc. If you have understood the preparation steps discussed earlier, you will see that responding to situational interview questions is not so scary. Overall, be truthful without being too humble. This is your time to share your accomplishments and provide specific examples of what you have done. A yes or no answer is generally insufficient. The interviewer is looking for you to cite a specific example and provide details of the situation, the actions you took and the results.

The STAR (Situation, Task, Action, Result) format commonly is used to respond to these types of questions:

• Situation: Describe the situation the interviewer has asked you about.
• Task: Describe what you wanted to achieve.
• Action: Describe specifically what you did to accomplish the desired task. It is important to focus on how and why you chose to do it that way. What steps did you have to take?
• Results: Now, it is time to share the outcome of your actions. Describe your achievements or how you met your objectives. When possible, cite quantitative results or specific details to give the interviewer the best illustration of your results. In some situations, you may want to describe what you learned from the experience and how you have adapted based on this learning.

Ask Questions

When it is your turn, be prepared with questions to ask your interviewer. Thoughtful questions not only make you appear interested and engaged, but also help demonstrate your suitability for the position.

Be Professional

Professionalism speaks volumes, although it is not shown only through speech. Be professional in your dress and demeanor as well. A professional appearance can imply a professional work product. Generally, a dark-colored suit is appropriate attire for a professional interview. A well-groomed appearance and clean, pressed clothing are just as important as not wearing anything too overpowering such as big jewelry or strong perfume. Treat interviewers with utmost respect, be punctual, use a strong handshake (but not one that will break the interviewer's hand), understand personal space and refrain from making comments about the interviewer's appearance, ethnicity or age.

Talk Money

In general, do not talk salary unless you have progressed to the interview with human resources. While compensation is certainly important, it is a faux pas to discuss this with the hiring manager, unless you are asked directly about your expectations. Even then, consider expressing a level of flexibility because it is important for the interviewer to know that other aspects of the job are just important.

Be Yourself, Be Different

Interviewers may see numerous candidates over a short period of time, which is why you want to make an impression that will stand out. If asked for one word that best describes you, avoid typical responses such as "diligent," "motivated" or "passionate" because they are soon forgotten. Think in advance about something distinctive that will easily be remembered. Do not forget to close the interview strongly and positively with a succinct summary of what you have to offer and clearly demonstrate why your talents as a regulatory professional and an individual are unique.

Post-Interview Etiquette

Thank You Notes

Remember to follow up an interview with a thank you note. Handwritten notes are always appreciated, but an email is just as good, especially when the interview process is time sensitive. Express gratitude and reiterate your strong interest in the position. Try to make each thank you note personal and specific to the interviewer. Interviewers often exchange notes or share their content, and it can be a letdown to find the same banal, impersonal note was sent to each interviewer.

Follow up

Unless you have been instructed otherwise,consider reaching out to the recruiter or hiring manager after a week or so and reinforce your interest in the job.

References

Make sure your references (ideally, one former supervisor, one or two colleagues and a direct report, if applicable) are on standby. Give them a copy of the job description and your resume so that they can speak to your experience and its relevance.

Conclusion

At the end of the day, the interviewers are going to select the person who is not only best qualified based on experience and credentials, but who also demonstrates the ability to succeed within the department and fits the company culture. Throughout the process, stay true to yourself and help the interviewer understand your capabilities and your personality.

When preparing for success on your next regulatory interview, keep in mind the wise words of tennis great Arthur Ashe: "One important key to success is self-confidence. An important key to self-confidence is preparation."

About the Author

Alyson Sous Andrikanich, PharmD, is an associate director of global regulatory affairs, advertising and promotion at Bayer HealthCare, where she is dedicated to the regulatory review of promotional materials. She holds a PharmD degree from the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, and completed a post-doctoral fellowship through the Rutgers Pharmaceutical Industry Fellowship Program. She can be contacted at [email protected].

Cite as: Andrikanich AS. "The Regulatory Interview: Preparing for Success." Regulatory Focus. February 2014. Regulatory Affairs Professionals Society.