Conversation With Nancy Singer: An Insider’s Perspective on Regulatory Affairs
For individuals aspiring for a profession in regulatory affairs, they may envision their career leading to positions in well-known agencies such as the Food and Drug Administration, or having the opportunity to help vital medical products safely gain market entry.
George Washington University’s (GW) Regulatory Affairs Professor, Nancy Singer, is well-versed in regulatory affairs. She shares her perspective as a subject matter expert and Chair of GW’s Regulatory Affairs Advisory Board. Here is her interview:
In 2004, you began your own regulatory compliance consulting company, Compliance-Alliance LLC. How did your experience and industry insight inspire you to begin your company?
Early in my career I was a prosecutor for the FDA, and then for a time I was an attorney in private practice. Later, I was special counsel for AdvaMed, the medical device trade association. As a general counsel for a medical products company, I observed that many people in our industry needed to improve their documentation practices. So, I created courses to teach people how to write documents that state the facts, explain issues, and provide specific details of compliance actions.
I created four courses, “Dangerous Documents: Avoiding Land Mines in Your FDA Records”, “Writing Under Pressure: Making It Easy”, “Talking to Decision-Makers: What to Say and How to Say It” and “Strategy at Meetings: Achieving Your Objective”.
I teach these courses not only to FDA officials and medical device and drug professionals, but also to students in the George Washington University’s Regulatory Affairs master’s program.
In your opinion, what factors are contributing to the growth within the regulatory affairs field?
Drugs and medical technology are being developed faster and more efficiently. Regulatory and quality professionals are needed to create regulatory strategies, submit applications to get the products cleared or approved by regulatory agencies, and ensure that companies manufacture high-quality products that are safe and effective. The role of the profession is changing. Regulatory strategy is becoming more important. Now, regulatory professionals are true business partners in companies.
What are the job opportunities for a career in regulatory affairs? What type of educational or professional background would be beneficial to someone looking to enter the field?
Today more people have access to health care, and more products are being developed. To guide the process and make sure new products are safe and effective, more regulatory professionals are needed both in industry and in regulatory agencies. While other industries are contracting, the medical products field is expanding and more people are entering the profession. To obtain a position in the field, applicants need to be able to distinguish themselves. Those who have a master’s degree and choose to attend a well- recognized university like GW show that they are motivated, have an interest in the field, and demonstrate that they are willing to spend the time and effort to get the needed expertise to advance in the profession.
GW’s program, specifically, sets itself apart. The fact that the Master of Science in Health Sciences (MSHS) in Regulatory Affairs is housed within the School of Medicine has the added benefit of enabling students to not only get the perspective of seasoned regulatory professionals, current and former regulators, but to also learn from medical doctors who use and prescribe medical products.
What advice would you give to current students or alumni?
Individuals should get as much education as possible, and learn about new regulatory developments by reading the trade press, and by meeting others in the field. They should also take advantage of opportunities to attend international symposiums such as GW’s Summer Institute in Regulatory Science, which, in collaboration with ECPM [European Center of Pharmaceutical Medicine], brought together quality professionals from around the world.
About Nancy Singer:
Professor Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for FDA and industry employees in the medical device and drug industries. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Professor Singer represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). While working on QSIT, she received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Professor Singer began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Professor Singer received her BS from Cornell University and JD and LLM degrees from New York University Law School. She is a retired commander in the United States Naval Reserve.
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