Title: Senior Advisor of U.S. Regulatory Policy and Director of U.S. Postmarket Regulatory Affairs
Company: Philip Morris International
Location: Bethesda, Maryland, United States
Piotr J. Kozarewicz, Senior Advisor of U.S. Regulatory Policy and Director of U.S. Postmarket Regulatory Affairs at Philip Morris International, has been recognized by Marquis Who’s Who Top Executives for dedication, achievements, and leadership in Regulatory Affairs.
Mr. Kozarewicz has established himself as a distinguished expert in regulatory affairs, with a career spanning over 25 years. Currently, he serves as the senior advisor of U.S. regulatory policy and director of U.S. post-market regulatory affairs at Philip Morris Products S.A. in Washington, D.C., a role he has held since 2025. In this capacity, Mr. Kozarewicz serves as the principal regulatory policymaker, coordinating regulatory work across the U.S., Switzerland and Sweden. He provides critical regulatory intelligence to drive strategies and tactics regarding post-market submissions and activities, ensuring the maintenance of Food and Drug Administration authorization for market smoke-free products. His leadership extends to managing the U.S. post-market regulatory affairs staff and projects.
Before his current position, Mr. Kozarewicz was the director of U.S. regulatory policy at Philip Morris Products S.A., also based in Washington, D.C., from 2024 to 2025. Before relocating to the U.S., he was the global head of regulatory affairs for smoke-free products in Neuchâtel, Switzerland, between 2023 and 2024. In this role, he played a key role in developing and implementing regulatory strategies that supported the company’s innovative product lines. Affiliated with Philip Morris since 2021, Mr. Kozarewicz began as the head of pre- and post-market regulatory management in Switzerland, where he served in this role for two years.
Mr. Kozarewicz also garnered success during his tenure as the regional head of regulatory and scientific affairs for the European Union from 2017 to 2021, where he played a pivotal role in navigating complex regulatory landscapes. Among other noteworthy roles that shaped his expertise in regulatory affairs, he was the head of evaluation procedures B at the European Medicines Agency in London, England, from 2014 to 2017, following his role as a scientific administrator between 2006 and 2014.
Earlier in his career, Mr. Kozarewicz held such positions as medical advisor at Novartis AG from 2005 to 2006, involved in registering medicinal products and collaborating with the marketing team, and regulatory affairs specialist at Schering-Plough Central East S.A. in Warsaw, Poland, between 2003 and 2005, where he was involved in coordinating regulatory affairs activities nationally. Mr. Kozarewicz initially gained experience as an assessor and quality assurance specialist at the Office for Registration of Medical Products, Medical Devices and Biocidal Products in Warsaw from 2000 to 2003.
Mr. Kozarewicz’s academic background laid a strong foundation for his professional achievements. After completing his undergraduate studies, he earned a Master of Science in pharmacy from the Medical Academy of Warsaw in 2000. His passion for his work and deep-seated curiosity have been driving forces behind his success, allowing him to explore new areas and uncharted territories within his field.
In addition to his professional endeavors, Mr. Kozarewicz is actively involved in civic-minded organizations, namely by supporting a local animal shelter. He has contributed significantly to academic literature with publications such as ‘Oral Medicines for Children in the European Paediatric Investigation Plans,’ co-authored in PLOS ONE in 2014 and ‘Novel Excipients: Regulatory Challenges and Perspectives – The EU Insight,’ co-authored in the International Journal of Pharmaceutics in 2018. Looking ahead, Mr. Kozarewicz aims to continue his professional growth and is contemplating stepping into a leadership role within his field.
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