Job Title: Director, Regulatory Affairs
Type of Company: My company is a mid-size biotech firm whose most promising research has gone into the creation of cell selection products using a magnetic antibody-antigen reaction.
Education: BS, Biology (minor in English)
Previous Experience: I started in product development at a diagnostic company, moved into technical support for another diagnostic company and then moved into Regulatory affairs at the same company. From there I moved up the ladder from specialist to supervisor to manager to associate director to my current position at two different biologics companies
Job Tasks: My primary responsibility as a Director of Regulatory Affairs is to make sure that my company functions in a way that is consistent with the laws and regulations surrounding the manufacture and use of medical devices and biologics. I work with two junior level regulatory affairs professionals and we support the clinical activities of the company for the United States. We submit information to the US Food and Drug Administration (FDA) to support the use of our products in clinical trials and promote the commercialization of those products that emerge from those trials. We support manufacturing, sales, marketing, clinical and senior management by directing their strategies to get our products to market as soon as possible, while still maintaining our compliance with FDA guidelines.
The one thing that is exciting about my job is that it changes so dramatically from day to day. One day I may be reviewing some advertising material (brochures, flyers, labeling) for our products, the next day I may be combing through manufacturing batch records to be sure that we are complying with the information submitted in our regulatory dossiers on file with FDA. We also deal with customer interactions, setting up clinical trials, reporting complaints to our quality assurance group and insisting that material is shipped according to standard operating procedures. Regulatory affairs allows me combine my science background with my writing skills.
Best and Worst Parts of the Job: The best part of my job is the diversity of my daily work experience and the opportunities it provides me with to interact with people at all levels of the company from the president to a manufacturing technician. It is exciting to have an impact on the future of the company. I also like the interaction with our customers and some of the thought leaders in our industry (oncologists, cardiologists, etc.)
The worst part of the job is the frustration I encounter in keeping people to deadlines.
1. Get a good background in science so that the terminology and concepts will not be foreign to you.
2. Embrace the English language. Learn how to write persuasively and to make your point as succinctly as possible.
3. Consider entering a company in either a manufacturing or quality assurance position to learn the basics of good manufacturing practices. Nearly everyone I know has entered Regulatory Affairs from some other part of the company.
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