When the Regulatory Affairs Professionals Society (RAPS) honored its 2012 class of RAPS Fellows last October during 2012 RAPS: The Regulatory Convergence in Seattle, the 12 newest Fellows joined an exclusive group of highly accomplished leaders. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions, vision and dedication toward the advancement of the profession.
Given that regulatory, as a profession, is relatively young and often invisible to those who are not intimately familiar with the regulatory process for healthcare products, RAPS Fellows are leaders by example. Their experiences, insights and advice are invaluable to those seeking to develop their regulatory careers. With that in mind, Regulatory Focus asked the current class of Fellows about their careers, their victories and their visions for the future. Following is an edited transcript of what they had to say.
How did you get started in the regulatory profession?
I came across an ad looking for someone with scientific background who was willing to learn. I applied and it turned out to be a medical device start-up company that needed someone to understand the regulatory requirements. So I joined the company and started exploring and researching and very quickly realized that it is a fascinating field that I wanted to become a part of. I guess one could say it was "love at first sight." - Shoshana Friedman, RAC, FRAPS, corporate vice president, quality assurance, regulatory and clinical affairs, NovoGI Inc.
I was working as a repair technician. I wanted to make the move to quality to stop the problems before the product was shipped to the customer. From there I moved into regulatory affairs. - Nancy Gertlar, RAC, FRAPS, senior assessor quality systems and regulatory affairs, ConMed Corporation
I came into it indirectly, and out of necessity, by becoming general counsel to the 3M Pharmaceuticals and 3M Drug Delivery Systems Divisions at 3M...I came to love the regulatory work over the rest of my general counsel work. - Mark DuVal, FRAPS, president, DuVal & Associates, P.A.
When I graduated from the University of Pittsburgh, I was looking for an interesting job for a couple of years with the intent of going to law school. I interviewed with the US Food and Drug Administration (FDA) for the position of investigator, thinking it would be an interesting job in an area that linked with my future career aspirations. Well that "short term" goal turned into an almost 30-year career! - Elaine C. Messa, RAC, FRAPS, executive vice president, medical device practice, Becker and Associates Consulting
What has been the most rewarding part of working in regulatory?
I have learned so much from meeting people from various countries and cultures that are so intelligent and interesting. Learning is a fundamental part of the experience gained over the years and has helped me become a better professional. - Philippe Auclair, PhD, FRAPS, senior director, regulatory strategy and Advocacy, Abbott
The opportunity to contribute to the marketing approval of many products, knowing human lives are being extended or enhanced. - Sathyanarayana M. Upadrashta, PhD, RAC, FAAPS, FRAPS, senior director, global regulatory affairs, CMC, Millenium: The Takeda Oncology Company
I love the relationships I've forged with agency personnel and contributing not only to my clients' success, but to the overall functioning of FDA as it interfaces with industry. I also enjoy the rigorous, spirited, high-level debates in which we engage about making the process better. FDA and industry take joint responsibility for speeding innovations beneficial to patients to market while protecting those patients as we do so. - DuVal
I find it extremely rewarding to have the opportunity to pass on my experiences to the next generation. I am teaching and training daily. What better legacy to leave? - David E. Chadwick, PhD, RAC, FRAPS, director, regulatory affairs/regulatory science, Cook Inc.
What does it mean to you to be honored as a RAPS Fellow?
There is no greater career honor than peer recognition for contribution to the profession. - David G. Parsons, PhD, FRAPS, vice president, regulatory affairs, GSK Consumer Healthcare
I have been very lucky to have come under the direct tutelage and profound influence of some world-class regulatory scientists. This is an opportunity for me to express my deep sense of gratitude to my mentors and colleagues from whom I have learned a great deal. It is time for me to give back to the association and to the regulatory sciences community through active mentoring efforts, identifying and executing important initiatives, and contributing to advancement of drug development and regulatory science. - Upadrashta
My career has always been about helping people get access to safe and effective new technology, and it is nice to be recognized for the work I have done. - Donna Bea Tillman, PhD, MPA, FRAPS, senior consultant, Biologics Consulting Group
What has been the most significant change you have seen in regulatory over the course of your career?
The regulatory profession continues to rapidly evolve and adapt. There have been some significant developments over the course of my regulatory career. Regulatory professionals are now moving freely between pharmaceutical and medical device companies. They are more knowledgeable about global regulations and submission requirements and are becoming increasingly aware of the complex, broader regulatory space. Also, senior management teams increasingly recognize the value that regulatory professionals add to identifying business development opportunities, designing mission-critical organizational strategies, and in ensuring overall corporate operational excellence. - Upadrashta
There have been changes at every level. Advances in technology, and in product science and complexity require us to be on our toes for perpetual learning. - Auclair
One of the strengths of the medical device regulatory program in the US has always been its risk-based approach. This has protected patients and allowed access to innovative products that have benefitted the American public. I am concerned that the current FDA device leadership seems to be moving away from this approach, and about what this may mean for the availability of the next generation of medical devices. - Tillman
In your opinion, what does the future of the regulatory profession look like? How will it be different in 10 or 20 years?
With new regulatory requirements being developed worldwide, the need for regulatory professionals will be even greater than it is today. Many countries are implementing new regulations and that will require many more professionals trained in regulatory affairs. - Bentsen
I believe the regulatory profession will continue the trend started in recent years of becoming a bigger player in the top management teams. As the world is becoming more regulated, more and more companies will realize that they need a regulatory affairs professional in their senior and executive level management to ensure they are making efficient and practical decisions. - Friedman
I expect that the regulatory field will become more important, challenging, interesting and exciting. Mobile health, stem cell research, genetic testing and treatment, miniaturization and combination products will not only change the product technology and treatment, but will change healthcare delivery and monitoring. - Messa
I believe the structure of dossiers will change to place much greater emphasis on the "fourth hurdles" of cost effectiveness and healthcare technology assessment. External relationships with regulators and healthcare funding agencies worldwide will become critical to successfully negotiating this new challenge. - Parsons
What advice would you offer someone just getting started in the regulatory field?
Try and get as broad an experience base as possible-Rx, OTC, devices, cosmetics-as today's healthcare businesses diversify, a wider range of experience is more likely to remain in demand. - Parsons
A career in regulatory cannot be done in isolation. It is the result of teamwork and the dedication of all the colleagues we work with every day. - Auclair
Take the time to learn by yourself and from colleagues, be patient and thorough, and try always to think outside of the box. - Friedman
My suggestion to new people in regulatory affairs is to become bilingual or trilingual with an educational emphasis in international business. - Gertlar
Get RAC certification, get a master's degree if you can, immerse yourself in your job and volunteer for many experiences. Stretch yourself continually. - Duval
The RAPS Fellows program is in just its sixth year, but each new class adds more collective wisdom to this this exclusive group. Perhaps a few more years into the future, when we ask the Fellows about their professional journeys, we will hear them cite some of these Fellows as mentors, examples and inspirations. The next class of RAPS Fellows will be welcomed in September at this year's annual RAPS conference, 2013 RAPS: The Regulatory Convergence in Boston. For more information about the RAPS Fellows program, visit RAPS.org/fellows.