‘Inside Regulatory Affairs’ With CHPA’s Mike Bailey, Marcia Howard And Jay Sirois
Executive Summary
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to CHPA’s Mike Bailey, senior vice president of regulatory and scientific affairs; and regulatory and scientific affairs VPs Marcia Howard and Jay Sirois.
HBW Insight is shining a spotlight on the work of regulatory affairs specialists operating in and supporting the consumer health and cosmetics industries. We are profiling this important role, hearing what a typical day involves and finding out what is top of mind for these individuals today. Look out for further installments in this series in HBW Insight over the coming weeks.
Regulatory affairs specialists in the OTC drug and dietary supplement industries, says the Consumer Healthcare Product Association’s Mike Bailey, likely end most workdays without deeming a project complete.
One reason for that is that more information constantly is being generated about manufacturing and marketing consumer health products, creating the potential for changes in maintaining regulatory compliance as well as in continuing production and distribution.
And managing those issues only begins with identifying them. Regulatory affairs specialists also are determining how to meet those challenges.
This article in HBW Insight’s series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries features Bailey, the CHPA’s senior vice president for regulatory and scientific affairs, and the trade groups VPs for the areas, Marcia Howard and Jay Sirois.
(Sirois) Since I started in CHPA’s Regulatory and Scientific Affairs Department in 2011, the responsibilities and the workload have certainly evolved. I am working on significantly more projects related to ingredient defense and advocacy on behalf of CHPA members. My role necessitates that I have a deep understanding of the science and regulations impacting the issues. However, I’ve also developed a greater understanding of how the work undertaken by our department cuts across several disciplines – communications, legal, and both state and federal government affairs – and the importance of cross-functional collaboration at CHPA. I’ve really been fortunate to work with and learn from several intelligent, dedicated people over the years who excel at their jobs and have helped me develop a greater understanding of the value the self-care industry brings to consumers.
CHPA Bios
- Bailey joined CHPA in April after previously leading Sanofi's consumer health care's scientific affairs for North America. His nearly four decades of scientific and regulatory affairs experience also has included work for other health care businesses, including Scios Inc., Bausch + Lomb, Corporation, Mylan Specialty, Boehringer Mannheim, Roche, Johnson & Johnson and Pfizer Inc. He's led the worldwide regulatory development, submission and approval of multiple new clinical trial applications and marketing applications, new drug applications, abbreviated and supplemental NDAs as well as investigational new drug applications and 510(K) device clearances.
- Howard joined CHPA in 2004 from the Department of Physiological Sciences at Oklahoma State University College of Veterinary Medicine. She has been scientific liaison for the CHPA Pediatric Cough Cold Task Group since 2009 and also assists with OTC medicine issues while coordinating its annual Regulatory, Scientific & Quality Conference. She is a member of the Drug Information Association, Regulatory Affairs Professional Society, Society of Toxicology and the American Society of Association Executives, where she was named to the ASAE Diversity Executive Leadership Program scholar class of 2016-2018 and received her designation as a certified association executive in 2018.
- Sirois has regulatory and scientific affairs activities responsibilities for cooperative programs with the FDA, ingredient safety and dietary supplement programs at CHPA. Prior to joining CHPA in October 2011, he was director of Pharmaceutical Development Group's Scientific Research and Clinical Studies. He is experienced in pharmaceutical, medical device and dietary supplement regulatory affairs, pharmacovigilance, Rx-to-OTC switch, product safety, and clinical research and is a member of the Regulatory Affairs Professionals Society and an ad hoc reviewer for the journal Neurotoxicology .