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Career Story: Regulatory Affairs Executive For A Pharmaceutical Contractor

Regulatory Affairs Executive For A Pharmaceutical Contractor

Job Title: Vice President, Regulatory Affairs

Type of Company: I work in the pharmaceutical industry for a company that is involved in contract research and development, contract manufacturing and packaging, and contract analytical services.

Education: BS, Biology, Rider University •• MA, Management, Central Michigan University •• MT(ASCP) certification, American Society of Clinical Pathologists •• RAC (Regulatory Affairs Certification), Regulatory Affairs Professionals Society

Previous Experience: I began my career as a clinical microbiologist and quickly found employment with pharmaceutical companies, working as a microbiologist in R&D. In time, I moved into Quality Assurance management and then Quality Assurance and Regulatory Affairs. Once in management, I ascended the ladder from Associate Director to Director to Sr. Director to Vice President.

Job Tasks: My primary responsibility is to provide regulatory consulting services to the various divisions of my company or to our customers. Our clients are pharmaceutical companies which outsource their regulatory affairs work to our company, work whose primary focus is obtaining FDA approval for new or experimental drugs.

On any given day, I can be contacted for my input on how the company or our client should proceed in surmounting a regulatory hurdle or developing a successful strategy for gaining FDA approval for a product. In fact, I will often be called on to act as liaison and primary contact with the FDA in discussions we hold with them regarding approval of a client's new drug. In that capacity, I arrange and conduct meetings with the FDA and try to figure out what the FDA requires and communicate this to the lab so that experimental data can be formatted to suit. I write or oversee the writing of so-called NDA's (new drug applications) and help to compile the regulatory data that's submitted to the FDA in support of those applications. Much of my work is involved with the interpretation of FDA rules, with helping design studies that will answer all of the FDA's questions and then assembling the scientific information into an easily understandable package that will garner their approval.

Best and Worst Parts of the Job: The best part of the job is that you get to research what is needed to gain approval of a product from the FDA and translate that into terms the scientists and researchers can work from. To understand what is needed for product approval usually involves in-depth technical analysis, talking to lots of people, reviewing FDA regulations and guidelines and scientific documentation.

The worst part is writing up the supporting documentation that defines and summarizes the analytical and clinical research in a way that's clear and comprehensible. It's more fun to develop the strategy for gaining approval than it is to write about the studies.

Job Tips:
1. Take as many courses as you can in your scientific discipline and in data structures or technical writing.

2. Develop good communication skills and make sure you consider joining an organization such as Toast Masters so you can hone your presentation skills.

3. Consider graduate work in regulatory affairs. Some universities now offer a Masters in Regulatory Affairs.

Additional Thoughts: The most important personal qualities you'll require are a zest for detail and good organizational and communication skills. I regret sometimes that, when I started out, there were no masters programs in Regulatory Affairs. If there had been, I would have pursued one.

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