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Preparing for a Job Interview in Regulatory Affairs

12/15/2009 4:29:25 PM


The pharmaceutical industry relies on regulatory affairs specialists to get their drugs approved by the FDA as quickly and cost-effectively as possible. Political pressure to decrease health care costs and the predicted contraction of the pharmaceutical industry places regulatory affairs professionals at an even higher demand. Still, this high demand doesn't mean positions aren't competitive. Extensive interview preparation will help you feel more relaxed so you can make the best impression possible.

Step 1

Get a sample job description from the human resources department or download one from the company's website. Use it as a guide to formulate sample interview questions. Be able to demonstrate how you are the ideal candidate by being able to address your qualifications for each job function.

Step 2

Prepare practice interview questions. Make a list of questions you would ask if you were interviewing a potential regulatory affairs specialist, such as "why are you the best candidate for this position" and "what major pharmaceutical companies have you worked with?" Also, be prepared to talk about your experience with regulatory agencies, ethical and OTC pharmaceuticals as well as devices and diagnostics you have worked with. See the resources sections for a list of sample interview questions if you have trouble formulating your own. Understand that well-prepared answers are integral to a good interview.

Step 3

Prepare results-based answers to the questions you've written. Use your answers to allow the employer to see how you can be an asset to the company rather than touting your accomplishments. Refrain from general statements like "I have a strong track record in regulatory affairs" and instead use specifics, like "I have guided more than 100 drugs to release, including several multi-billion dollar releases." Mention applicable theses, documents, or dossiers that you have written in the past.

Step 4

Practice your responses to your sample questions by saying them out loud, several times. Be able to answer the question naturally without sounding like you're giving a rehearsed or canned answer.

Step 5

Research the company. Learn about its mission or vision and its key strategies. Find out what major drugs they've produced and what new drugs they have in development. Also, prepare some questions that aren't readily available on their site. Your questions and demonstrated knowledge of the company shows them that you are interested and invested in them.

Step 6

Assemble a portfolio. Bring an additional copy of your resume and cover letter. It's likely this information was reviewed by human resources while your interview could be conducted by your future boss. Have any supporting documents that prove your track record in regulatory affairs. Include a writing sample, preferably a request for drug approval or other relevant document. Block out confidential information if necessary. Only present this information if asked for or about it.


Understand general job interview etiquette. Never ruin an otherwise great interview by inadvertently presenting yourself unprofessionally. See the resources section for information on job interview etiquette, such as how to dress, when to arrive, and what not to say.

References Biotech and Pharmaceutical News & Jobs
U.S. Department of Labor
Regulatory Affairs Interview Questions
Kelly Scientific Resources Center
Job-Clinching Interview Secrets and Tips by Nimish Thakkar, Career Coach

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