Kalpana Venkataraman

I have spent 34 years in the pharmaceutical industry, with 30 years dedicated to regulatory affairs and product labeling development. As a Principal Consultant, I support prescribing labeling development for diverse therapeutic areas across global regulations. What inspires me most about this field is that product labeling is truly the place where you touch every scientific discipline in drug development. As a subject matter expert, I work across divisions in major pharma companies, collaborating with leadership and scientists who live close to the data, and translating that into prescribing information that goes directly to physicians and patients. Every day is a learning experience because each drug has its own exciting development path, and the rules and regulations are specific to each market and region. I have supported quite a few drugs that truly helped patients, including members of my own family and even myself. There is an incredible sense of achievement when you become a patient taking a drug you helped develop. Currently, I focus on oncology drug development, which is especially satisfying because we are helping patients in acute situations and extending their lives. Beyond my technical work, I am deeply proud of my role as a teacher and mentor. Throughout my career, I have trained countless newcomers to the labeling world, conducting voluntary weekly classes within organizations to help employees build their knowledge through real-world scenarios. I have been told again and again that I am one of the best teachers of new employees in my functional area, and this teaching role has continued throughout my entire career.