Book Excerpt: How I Got Started in Regulatory

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As a microbiology major graduating in the early 1980s, I faced slim opportunities for employment in my chosen career field. I searched for the "right job" for three months and, with no real prospects in sight, I decided to work for an upstart airline. I know, a far cry from regulatory affairs, but in the big picture, the 18 months I spent working there taught me a lot about myself and the business world.

I did eventually find my coveted microbiology position at a generic drug company in 1983. Fresh from the passage of the Hatch-Waxman Act, the generic drug business was growing. I was involved in all aspects of the three-person laboratory, from Quality Assurance to antibiotic development. And, oh yes, washing all the glassware!

I started to get the itch to find the "perfect job" about 18 months after joining the generic drug company. During a meeting of the local branch of the American Society of Microbiology, an acquaintance told me about an opportunity at a local, family-owned pharmaceutical company (note-networking, even among science nerds, does pay off). It was quality control microbiology work, but I would work closely with research and development at corporate headquarters; it was 10 miles from home and it meant a pay raise. I applied, interviewed and was hired. The year was 1985, and little did I know that I would spend the next 19 years working for this company and, eventually, the company that bought it, pursuing three different career paths.

Jump to 1988: I now had five years under my belt as a microbiologist and was burning out. I needed a change, but more importantly, I needed a challenge. Lab work just was not what I wanted to do. My boss saw that I was unhappy and suggested that I apply internally for one of the Quality Assurance (QA) positions that had been posted recently. It would mean a longer commute, as the position was at corporate headquarters, but this was my chance to move out of the lab. In the bigger picture, I realized if I were ever going to grow within the company, I would have to be where the action was.

QA was a welcome change and a challenge. I spent five years in QA. It was a great place to learn and interact with many different parts of the organization. I often had lunch with colleagues from other departments. One group, regulatory affairs, seemed to have a very exciting and highly visible presence. I tried to get the team to explain what they did, but they all seemed to struggle with a definition. One member of the group told me about a program she was attending at the Arnold & Marie Schwartz College of Pharmacy at Long Island University in pursuit of a master's degree in drug regulatory affairs. It was at night; I could commute with her and the company would pay for it. What was there to lose? So, in the autumn of 1992, I enrolled in the program. Within a few weeks, I began to understand why my lunchmates had difficulty defining their jobs. There was so much complexity and variety that it was hard to pinpoint-this was exciting stuff!

After the first semester, I was hooked! I continued in the program until 1993, when the unexpected happened; the person who had originally suggested that I attend the program decided to leave my company. But before she did, she told her boss that I would be a great replacement. He asked whether I would be interested in a position in the international regulatory affairs department. I do not remember saying yes, but I must have done so, as within the month, I started as a regulatory specialist.

And yes, I did receive my degree.

I had a great boss and mentor at that pharmaceutical company. He challenged me at every turn and kept me on my toes. By the time the company was sold in 2001, I had moved up the regulatory affairs ladder to associate director. I want to pay back the profession and can think of no better way than to mentor the next generation of regulatory professionals.

In summary:

• Networking: One of the most important tips I can give those breaking into the profession is to start networking. This need not be costly; it can be as simple as joining an online discussion or study group or a professional association that supports the regulatory function-the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA) or The Organisation for Professionals in Regulatory Affairs (TOPRA).
• Mentoring: perhaps your employer has a mentoring program. If you want to move up in the company or perhaps transition to a new area, look for a person you admire for passion and work ethic. Remember, mentoring is not the same as career counseling.
• Communication skills: These are important to a regulatory professional, whether for an internal meeting, a professional presentation or discussions with a health authority. I have found that volunteering to speak at internal meetings is a great way to prepare for the outside world. I honed my skills as a member of a community theatre, where I learned to become fearless in front of audiences. I also attended Toastmasters, a venue where my peers could assist and critique my style.
• Volunteer: Start a "lunch and learn" at your company or help with registration at local events-you need not be a presenter in order to become involved.
• Challenge: Accept challenge gracefully and let it be your driver. Be willing to learn, even if it is outside your comfort zone. You never know when it may come in handy. Do not be afraid to ask questions. We were all newcomers at one time!
• Education: There are many regulatory certificate, master's and doctorate programs available to you. This is a chance to learn, communicate and network.
• "Hard knocks:" Many of us started in the "school of hard knocks." You may need to work in a regulatory support function before getting the job you want.
• Passion: Have a passion for what you do; your job will be much easier and more enjoyable.

So here I am, 17 years after landing my first regulatory affairs position, and I have found that "perfect" career.

About the Author

Linda Bowen, MS, RAC (US, EU, CAN), FRAPS, is head of US regulatory policy and intelligence at Sanofi. During her more than 30 years in the pharmaceutical industry, she has held regulatory and quality positions with global regulatory responsibilities for submissions, lifecycle management and due diligence activities. Bowen received an MS in drug regulatory affairs from the Arnold and Marie Schwartz College of Pharmacy and Health Sciences. She has earned Regulatory Affairs Certification (RAC) for the US, Canada and Europe, and was an inductee to the Regulatory Affairs Professionals Society's (RAPS) 2011 Class of Fellows. Bowen is a past two-term member of the RAPS Board of Directors, past chair of the New Jersey/New York RAPS Chapter, an RAC study group facilitator, and a RAPS annual conference committee member. She can be reached at linda.bowen@sanofi.com.

Cite as: Bowen, L. "How I Got Started in Regulatory." Regulatory Focus. February 2014. Regulatory Affairs Professionals Society.