Global Head of Regulatory Affairs
Arlene Wolny is the Global Head of Regulatory Affairs at Biocon Biologics and oversees the Company’s regulatory practices worldwide.
Arlene joined Biocon Biologics in November 2023. With over 15 years of experience in the pharmaceutical industry, Arlene is a seasoned professional specializing in strategic regulatory science and risk management. Her expertise in developing regulatory strategies will be instrumental in helping advance Biocon Biologics’ pipeline products through their ‘lab to market’ journey, ensuring the delivery of the Company’s biosimilars to patients worldwide.
Her deep understanding of emerging trends in the pharmaceutical sector, coupled with adept navigation of complex, country-specific regulations, will allow Biocon Biologics in meeting or surpassing the evolving expectations of international regulatory agencies.
In her capacity as the co-chair of the Biosimilars Council, Arlene has played a pivotal role in aligning industry objectives with the guidelines of the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services. She is also a valued member of the Association for Accessible Medicines (AAM), BIO, and other industry associations.
Prior to joining Biocon Biologics in November 2023, Arlene held senior regulatory positions in renowned global pharmaceutical companies. Notably, she spent 11 years at Novartis, where she served as the Executive Director of Oncology Program Management. Before that, Arlene contributed her regulatory expertise to Sandoz, where she held the position of Head of U.S. Regulatory Affairs.
Arlene holds a Ph.D. in Pharmacology from the University of Basel, Switzerland, and an MBA in Finance from Columbia Business School in the U.S.