04.10.24
The Consumer Healthcare Products Association (CHPA) has appointed Michael A. Bailey to serve as its new senior vice president of regulatory and scientific affairs. Bailey has spent nearly four decades in scientific and regulatory affairs at leading healthcare companies, and will begin his work on April 15, where he will report to Scott Melville, president and CEO, and be a member of the association’s senior management team.
Bailey most recently served as head of scientific affairs for North America at Sanofi Consumer Healthcare, in addition to working on the regulatory programs of several industries such as brand and generic prescription drugs, over-the-counter (OTC) consumer products, devices, cosmetics, and nutritional and dietary supplements. Bailey’s career has spanned several corporations, some of which are CHPA members, including Scios, Bausch & Lomb, Mylan Specialty, Boehringer Mannheim, Roche, Johnson & Johnson, and Pfizer.
Bailey has specialized in the development, submission, and approval of new clinical trial and marketing applications, such as Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Supplemental New Drug Applications (sNDAs), and 510(K) device clearances.
He has helped launch numerous drugs, devices, dietary supplements, and cosmetics, managing compliance, maintenance, and life cycle development of over 100 investigational and marketed products.
He has also managed 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 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.”
Bailey will oversee all aspects of regulatory and scientific affairs at CHPA. He’ll lead task and working groups and committees, strengthen relations with FDA, and cover additional regulatory priorities while leading his department.
“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 a member of multiple leadership and management boards, research and development leadership teams, and global regulatory affairs leadership teams, and will be based at CHPA’s Washington, D.C. headquarters.
Bailey most recently served as head of scientific affairs for North America at Sanofi Consumer Healthcare, in addition to working on the regulatory programs of several industries such as brand and generic prescription drugs, over-the-counter (OTC) consumer products, devices, cosmetics, and nutritional and dietary supplements. Bailey’s career has spanned several corporations, some of which are CHPA members, including Scios, Bausch & Lomb, Mylan Specialty, Boehringer Mannheim, Roche, Johnson & Johnson, and Pfizer.
Bailey has specialized in the development, submission, and approval of new clinical trial and marketing applications, such as Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Supplemental New Drug Applications (sNDAs), and 510(K) device clearances.
He has helped launch numerous drugs, devices, dietary supplements, and cosmetics, managing compliance, maintenance, and life cycle development of over 100 investigational and marketed products.
He has also managed 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 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.”
Bailey will oversee all aspects of regulatory and scientific affairs at CHPA. He’ll lead task and working groups and committees, strengthen relations with FDA, and cover additional regulatory priorities while leading his department.
“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 a member of multiple leadership and management boards, research and development leadership teams, and global regulatory affairs leadership teams, and will be based at CHPA’s Washington, D.C. headquarters.
