With over 15 years of experience in the pharmaceutical industry, Arlene Wolny is a seasoned professional specializing in strategic regulatory science and risk management. She will leverage her expertise in developing regulatory strategies to 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 an adept navigation of complex, country-specific regulations, will enable Biocon Biologics to meet and surpass the evolving expectations of international regulatory agencies.
Prior to joining Biocon Biologics in November 2023, Arlene held senior regulatory positions in well known global pharmaceutical companies. Notably, she spent 11 years at Novartis, where she served as the Executive Director of Oncology Program Management. Before that, she contributed her regulatory expertise to Sandoz, where she held the position of Head of U.S. Regulatory Affairs.
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. 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.
Arlene holds a PhD in Pharmacology from the University of Basel, Switzerland, and an MBA in Finance from Columbia Business School, USA.
