“Building relationships is just as important as the technical aspects of my role”
Janet Vaughn is Vice President for Regulatory Affairs, North America Generics. She has worked in pharmaceutical regulatory affairs for nearly 30 years, more than 20 of them at Teva, and in December 2020 was appointed Head of Regulatory Affairs for Teva’s North America Generics business. 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.
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, license, manufacture and marketing of medicines and devices. The combination of science, compliance and ethics really appealed to me and I saw the importance of protecting and promoting public health within a legal framework through the application of sound scientific knowledge. When I had the chance to move into regulatory, I jumped at the opportunity and now I can’t imagine working anywhere else.
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 both 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 the work I do, I’d say you must love the challenge of figuring how to present a strong scientific case for your product within the regulatory framework.
The best part of my job is being able to work with a team of talented, professional and technically sound individuals. Our joint effort in resolving various issues has not only strengthened my knowledge of regulatory affairs but has also given me a real sense of accomplishment.
Building relationships is just as important as the technical aspects of my role. Regulatory affairs leaders are responsible for ensuring that the company follows the rules and regulations set by regulatory agencies. 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. Open dialog with regulatory agencies 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.
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 and I truly enjoy working with them. Despite being a department 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 co-workers 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.
I enjoy travel and have been on many trips around the world, to several European countries, as well the Caribbean, South Korea, Iceland and Costa Rico. Now that we have the COVID-19 vaccines and it’s safer to travel, I am excited about my plans to visit U.S. national parks in the Dakotas and Utah this summer with my husband.
We all encounter challenges at some point in our lives but none are too great to overcome. My own experiences have taught me the importance of placing each challenge in perspective, never losing focus of what truly matters - life, love, health, family and friends.
The last book I read was Becoming by Michelle Obama. I really enjoyed it.
Cory Wohlbach is responsible for steering Teva’s new biosimilar products through the regulatory approval process. He explains what biosimilars are, how they have the potential to reduce costs for patients and how patient safety is always a top priority.