(WASHINGTON, D.C.) – The Consumer Healthcare Products Association (CHPA) today announced the appointment of Michael A. Bailey to serve as its new Senior Vice President of Regulatory & Scientific Affairs. Having nearly four decades of extensive scientific and regulatory affairs experience at leading healthcare companies, Bailey will bring a diverse wealth of knowledge and expertise to CHPA’s regulatory department. He will officially begin his work at CHPA on April 15, 2024. Bailey will report to CHPA President and CEO Scott Melville and will be a member of the association’s senior management team.
Most recently serving as Head of Scientific Affairs for North America & the U.S. at Sanofi Consumer Healthcare, Bailey brings an extensive track record of regulatory affairs experience to CHPA. Throughout his career, he led global, regional, and U.S. regulatory programs across various healthcare sectors and categories, which include brand and generic prescription drugs, over-the-counter (OTC) consumer products, devices, cosmetics, and nutritional and dietary supplements. Bailey’s career has spanned across other renowned healthcare corporations, including several CHPA members, such as Scios, Bausch & Lomb, Mylan Specialty, Boehringer Mannheim, Roche, Johnson & Johnson, and Pfizer.
Bailey has demonstrated exceptional leadership in driving regulatory strategy and execution, with career accomplishments that include:
- Leading the worldwide regulatory development, submission, and approval of multiple new clinical trial applications and marketing applications, including numerous Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Supplemental New Drug Applications (sNDAs), and 510(K) device clearances;
- Launching numerous drug, device, dietary supplements, and cosmetic products, while managing compliance, maintenance, and life cycle development of more than 100 investigational and marketed products; and,
- Managing Risk Evaluation and Mitigation Strategies (REMS) programs, while working with the U.S. Food and Drug Administration (FDA) to develop one of the first product risk management programs.
"I am extremely pleased to welcome Mike as the new leader of CHPA’s regulatory and scientific affairs team," said President & CEO Scott Melville. “Mike’s decades of experience will be enormously helpful in CHPA’s efforts to protect and promote self-care options for consumers. As our industry approaches reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA), seeks to enhance the Rx-to-OTC switch pathway, continues working to modernize the regulatory framework for dietary supplements, and enables advances in consumer devices and digital health, Mike’s proven track record will be critical. His success in working with FDA, leading teams through advisory committee meetings and congressional briefings, among other strengths, will be instrumental in helping to shape the complex regulatory framework and policies that contribute to expanded product access for the communities we serve. It’s an honor to welcome Mike to the team, and I very much look forward to working together to shape the future of self-care.”
In his new role, Bailey will oversee all aspects of regulatory and scientific affairs at CHPA, including: leading task groups, working groups, committees; strengthening relations with FDA leaders, centers, divisions, and offices; and additional regulatory priorities for the association, while leading a talented and experienced department at CHPA.
“I’m honored and excited to join CHPA and lead its regulatory and scientific affairs team,” said Bailey. “Coming to CHPA from a member company, gives me a unique understanding and perspective of the vital role trade associations play – and CHPA in particular – in advocating on behalf of our industry and the consumers we serve. When it comes to this work, CHPA’s efforts are not just about shaping regulations and policies, but they’re about safeguarding the foundation of a sector that empowers Americans through the expanded choice and availability of trusted consumer healthcare products. I’m honored to take on this new role and look forward to helping advocate for reforms that drive progress, modernization, innovation, growth, and foster happier, healthier lives for all.”
Bailey graduated from West Virginia University with a bachelor’s degree in animal science and holds a master’s degree in business from Johns Hopkins University. He is an experienced member of multiple leadership and management boards, research & development leadership teams, and global regulatory affairs leadership teams. He currently resides in Lafayette, New Jersey, with his wife of 34 years and three children, and will be based at CHPA’s Washington, D.C. headquarters.