Meet the expert: Janet Vaughn, Vice President, Regulatory Affairs, North America Generics
Janet Vaughn has worked in pharmaceutical regulatory affairs for nearly 30 years, more than 20 of them at Teva.
In December 2020, Janet was appointed Head of Regulatory Affairs for Teva’s North America Generics business. One in ten of the 3.66 billion generic prescriptions written in the United States is filled with a Teva product, 01 and the company manufactures more than 500 generic prescription and over-the-counter products in more than 2,000 dosage strengths and package sizes, including oral solid dosage forms, injectable products, inhaled products, liquids, ointments and creams. 02 Leading the team responsible for regulatory affairs for one of the largest and most diversified generics portfolios in the industry, Janet explains the importance of building relationships and what separates great leaders from good ones.
The convergence of science and public health within a legal and compliance framework drew me to regulatory affairs. I started my pharmaceutical career as an analytical chemist in a laboratory. I observed how my regulatory affairs colleagues partnered with all parts of the business to help navigate the regulatory framework in the development, licensure, manufacture and marketing of medicines and devices. I admired the important role our regulatory affairs officers held in protecting and promoting public health within a legal framework through the application of sound scientific knowledge. The combination of science, compliance and ethics really appealed to me. I reached an inflection point in my career when I had the choice to advance my career in drug development or move into regulatory. I jumped at the opportunity to pivot to regulatory affairs and now I can’t imagine working anywhere but regulatory affairs.
Regulatory Affairs gives me a 360-degree view of pharmaceuticals. Medicines regulation touches all aspects of the pharmaceutical business and impacts every step in the drug development process. At Teva, the Global Regulatory Affairs organization focuses on our license to develop, manufacture, import, export, and distribute medicines and medical devices. Our organization helps manage assessments of scientific data used to demonstrate the safety, efficacy and quality of each individual product in Teva’s global portfolio.
Innovation happens in drug development and in regulatory affairs. As science, medicine and technology evolve, regulatory guidelines change – and not always at the same pace or in sync. We push each other forward. To be successful in regulatory affairs, I’d say you must love the challenge of figuring how to present a strong scientific case for your investigative product within the regulatory framework.
Building relationships is equally important to the technical aspects of my job. Regulatory affairs leaders are responsible for ensuring that the company adheres to the rules and regulations set by regulatory agencies. At the same time, as a leader in generics drug development, Teva pushes the boundaries of science and often works closely with health authorities to test new strategies and approaches for data packages that corroborate sameness to reference products in compliance with regulations. Open dialog with U.S. Food and Drug Administration personnel is very important, especially for complex products. The key is trust and transparency. My team is able to have productive conversations with regulators because of the trust we’ve established over the course of long-term professional relationships.
Great leaders have this one characteristic in common. To me, empathy separates the great leaders from the good ones. What is easy for me might be challenging for someone else. It takes empathy to meet people where they are and to embrace -- not just accept -- the fact that we’re all individuals with different experiences, approaches and abilities. There’s more than one way to get something done right.
It might sound cliché but really, my team is like my family. I truly enjoy working with the people in my organization. Despite being an organization comprised of roughly 120 individuals based in different locations, we are a team-oriented group and we learn from each other. We respect the fact that we each come from diverse backgrounds and recognize that each of us has a unique and valuable contribution to make. I've worked with some members of the group for 20 years, and they’ve become more than just coworkers to me.
I love to laugh. Laughter is a big part of who I am. My family loves to kid around, play jokes and tease in a loving way. At Teva, the work we do for patients and the interactions we have with regulators are taken quite seriously, and when appropriate, laughter in the workplace helps make the day more enjoyable and brings the team together. Laughter is a universal language.