Below are the members of our prestigious Board of Directors. Learn more about the positions and their duties.
Jethro Ekuta DVM, PhD, EMBA, RAC, FRAPS
Jethro Ekuta is chief regulatory and safety officer at Ascendis Pharma, where he heads global regulatory affairs and pharmacovigilance. Previously, he was vice president, head of regulatory science delivery at Alexion, AstraZeneca Rare Disease and senior vice Ppresident, global head of regulatory, safety and standards at Horizon Pharmaceuticals. Before that, he held regulatory and pharmacovigilance roles of increasing responsibility at companies that included Johnson & Johnson, Genzyme-Sanofi, Bristol-Myers Squibb, Pfizer, and Procter & Gamble Pharmaceuticals. Prior to joining industry, he was a staff fellow in clinical pharmacology at the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER). He completed his US National Institutes of Health (NIH)-sponsored post-doctoral fellowship training in neuropharmacology and cardiovascular pharmacology at Meharry Medical College, and an FDA-sponsored post-doctoral fellowship in clinical pharmacology at Vanderbilt University Medical Center. He earned his RAC-US credential in 2010 and is a RAPS Fellow.
Ayse Baker PhD, MBA, FRAPS
Ayse Baker is the vice president of corporate regulatory affair at Corcept Therapeutics. She has over 25 years of experience in the pharmaceutical industry with a focus on building and leading regulatory affairs teams worldwide. Ayse received a PhD in chemistry from University of Illinois at Chicago, an MBA from Lake Forest Graduate School of Management, and completed her post- doctoral fellowship at Loyola University. She started her pharmaceutical career at Abbott Laboratories as a research scientist.
Ayse is a frequent speaker in national and international trade organizations and prestigious academic institutions. She was recognized for her contributions to the regulatory affairs profession and became RAPS Fellow in 2016.
Ayse is a frequent speaker in national and international trade organizations and prestigious academic institutions. She was recognized for her contributions to the regulatory affairs profession and became RAPS Fellow in 2016.
Diana Salditt FRAPS
Diana Salditt is Principal Consultant at Salditt Regulatory Consulting LLC, specializing in regulatory policy, strategy, and science. She is a RAPS Fellow and expert in global policy and regulations for medical devices and combination products. Diana is a leader and contributor to organizations that advance public health and policy and foster professional development and thought leadership. At Medtronic, she was a senior policy leader and advisor in global regulatory affairs. She also held regulatory positions in Medtronic’s neurological and cardiac surgery businesses and in the in vitro diagnostics industry.
Patricia Reis Castro CPA
Patricia Reis Castro is a quality and regulatory executive with extensive experience in the medical device industry. Currently, she serves as the Director of Postmarket Surveillance for Abbott Diabetes Care. Previously, Patricia worked at GE HealthCare for nearly 20 years, where she held various roles including, Associate Auditor, Business Controller, Sr. Director of Global Regulatory Affairs, and Executive Postmarket Surveillance. Her expertise in postmarket surveillance and regulatory affairs includes complaint handling, adverse event reporting, CAPA, and compliance auditing processes. She also has a background in global pre-market medical device registration processes.
Bill McMoil MBA
Bill McMoil joined RAPS in 2017 as Chief Operating Officer and has served as Executive Director since April 2020. Since joining RAPS, McMoil has grown the organization from 26,000 to 35,000 members globally; staff from 40 to 60; and annual revenue by 57%. By expanding RAPS portfolio of products and services, he has championed innovative and effective solutions to address the diverse educational needs of the regulatory profession and has built a vibrant collaboration with the RAPS volunteer base (boards, committees, and chapters) in support of RAPS’ diverse, and geographically distributed community. RAPS’s European presence has expanded significantly during McMoil’s tenure, with membership and RAPS Euro Convergence event more than doubling. McMoil has also ensured that RAPS promotes itself as an ethical, neutral, and non-advocacy community for its regulatory members to connect, learn and share ideas.
Daniela Drago PhD, RAC, FRAPS, FTOPRA
Daniela Drago is a Partner at NDA Partners. She has significant domestic and international experience developing small molecules, biologics, gene and cell therapies, and combination products in many rare and common disease areas. Drago held leadership roles in the pharmaceutical and biotech industries, consulting organizations, and academic institutions. She worked for companies ranging in size from start-ups to Fortune 500, including Roche, Biogen, and Bausch & Lomb. She was formerly an Associate Professor at George Washington University’s School of Medicine, where she also directed the regulatory affairs and the clinical & translational research programs. Currently, she is affiliated with the University of California, San Francisco, American Course on Drug Development and Regulatory Sciences, and the University of Basel, European Center of Pharmaceutical Medicine.
Nancy Gertlar RAC, FRAPS
With four decades of distinguished experience in the medical device and related industries, Nancy Gertlar is recognized internationally as a leader in global regulatory affairs and quality management systems. Her leadership extends across both multinational corporations and startup organizations and has consistently guided trans-global teams in the development and implementation of advanced regulatory and quality strategies. Possessing comprehensive knowledge of both US and international medical device regulatory and quality management system requirements, Nancy brings hands-on experience in facilitating global regulatory submissions, securing product certifications, and managing complex cross-functional projects. She has served as the formally designated liaison between industry, FDA, the European Commission, standards associations, and patient safety groups, further establishing her reputation as a frequent public speaker in several countries. Nancy is a RAPS Fellow and holds the RAC-US, RAC-EU, and RAC-Canada credentials.
Megha Iyer MS, RAC, FRAPS
Megha is a highly skilled Regulatory Affairs professional with extensive experience in the Life Sciences, Medical Devices, and In Vitro Diagnostic devices industry. She has a proven track record of success in both operational and strategic aspects of regulatory affairs. She has led global teams with a wide range of portfolios and collaborated with regulatory authorities to guide the development of new policies and regulations. Currently, Megha is the Director of Global Strategic Regulatory Affairs at Thermo Fisher Scientific, shaping regulatory intelligence, policy, and advocacy across the organization's diverse businesses. She occupies leadership positions in industry associations like MedTech Europe & the Association for British Healthcare Industry (ABHI) influencing the development of patient-centric regulations. Megha is also dedicated to the professional growth and development of the next generation of regulatory leaders. She has a longstanding involvement with RAPS most notably as the Chair of the RAPS Global Convergence Planning Committee. Megha holds an M.Sc. in Biotechnology, an M.S. in Bioscience Regulatory Affairs, and the prestigious RAC US designation, showcasing her expertise and commitment to excellence in the field.
Jocelyn Jennings MS, RAC, FRAPS
Jocelyn Jennings is vice president, regulatory affairs and quality assurance at Mycovia Pharmaceuticals, Inc. She has over 27 years of extensive global regulatory affairs, quality assurance, and global clinical trial experience in drugs, biologics, medical devices and combination products. She has held leadership roles at small and large biopharmaceutical and medical device companies in various therapeutic areas such as oncology, immunology, women’s health, and rare diseases. Jennings is an adjunct professor at Northeastern University in their College of Professional Studies Masters of Regulatory Affairs Program. She has been actively involved as a volunteer with RAPS for over 10 years, authoring chapters and regulatory books for RAPS, authoring RAPS articles, contributing to Regulatory Focus, and helping develop online courses. Jennings also serves on the RAPS Editorial Advisory Committee and the Regulatory Affairs Certification Board. She is a RAPS Fellow.
Lawrence E. Liberti PhD, BPharm, RAC
Dr Liberti has worked in the fields of pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. He began his career at Wyeth Laboratories working in product development, then as a regulatory writer in clinical R&D, and manager of safety surveillance in medical affairs. He served as the editorial director for the North American operations of ADIS international after which he founded PIA Ltd, a company specializing in regulatory writing and consulting; he co-founded Astrolabe Analytica under which he helped develop, patent and commercialize the Astrolabe Message Mapping System.™
Mindy McCann FRAPS
Mindy McCann is vice president of US Operations and a Principal Consultant with Qserve Group USA, specializing in global regulatory affairs, quality systems and clinical for medical devices. She has over 30 years of multi-faceted hands-on medical device regulatory experience, having worked for a start-up, a large global company, and two notified bodies, prior to consulting. McCann’s has experience in executive-level regulatory affairs and business management positions, consulting, regulatory specialist, product reviewer, auditor, and development and process engineering. She is a RAPs Fellow.
Jennifer M. Paine MS, RAC, FRAPS
Jennifer M. Paine has more than 20 years of cross-functional experience in global, executive roles in the health care industry. In her current role as Chief Quality Officer for Johnson & Johnson, she is responsible for partnering with regulators, health authorities and other stakeholders to accelerate innovation from Johnson & Johnson’s pipeline to improve the lives of patients globally. Paine served four years on the AdvaMed Dx Board of Directors where she also held the role of Regulatory Vice Chair (2014-2019). She has also served as vice president/president of the Healthcare Businesswomen’s Association (HBA) Central New Jersey Chapter Board, working to further the impact and advancement of women in healthcare, and is a member of Women Business Leaders and Women50.
Beat U. Steffen, RAC, FRAPS
Beat U. Steffen is founder and principal consultant at confinis ag, specializing in regulatory affairs, quality management, and clinical affairs. He has more than 30 years of industry experience as an expert in global regulations for medical devices and combination products. Beat is a lecturer at Bern University and the University of Applied Sciences and is a co-founder and chairman of Medical Human Factors AG, a company specializing in evaluating the use related safety, effectiveness and usability of medical products. He also serves as a lead auditor for a certification body around medical devices and pharmaceutical packaging. Before that, he built up and spear-headed the project management and risk management departments at Ypsomed. Beat is a RAPS Fellow and holds the RAC-Devices credential.
Yoshiko Stowell, PhD, RAC, PMP
Yoshiko Stowell is vice president of regulatory affairs at Kenai Therapeutics, where she leads development of cell therapies for neurodegenerative diseases. Previously, she was head of regulatory affairs at Neuron23 and AmyriAD Pharma, where she led development of small molecules for neurodegenerative diseases. Before that, she held regulatory, clinical operations, and project management roles of increasing responsibility at Eidos Therapeutics/BridgeBio, Impax/Amneal Pharma, Teikoku Pharma USA, and Alza Corporation/Jonson and Johnson. She received her doctorate in pharmaceutical science from University of the Pacific, her master’s in chemical engineering from University of Oklahoma, and her bachelor’s degree in pure and applied chemistry from Tokyo University of Science. She has served as the RAPS San Francisco Bay Area Chapter Chair. She holds a RAC-Drugs credential.
Board Position Description & Duties
The Board of Directors is composed of officers and directors with defined responsibilities that support effective governance and leadership of the organization. Interested in participating? Learn about the nomination process.
The board meets three to four times per year, with half-day to one-day meetings, and conducts other business through teleconference and/or electronic communications. Members of the board must be able to allocate appropriate time and attention to the work of the board and to work on behalf of RAPS without regard to personal gain. Where possible, board members are encouraged to support some travel expenses with their employer’s support.
Chairman
The Chairman is the chief elected official of RAPS and will preside at all membership, Board of Directors and Executive Committee meetings. The Chairman cannot be re-elected to serve as an Officer or Director of RAPS following the completion of the term as Chairman.
President
The President of RAPS will assume without election the office of Chairman at the expiration of the term of the incumbent. In the absence of the Chairman, the President will preside at meetings of the membership, Board of Directors or Executive Committee and will perform other duties, as assigned by the Chairman.
Treasurer
The Treasurer will review RAPS' quarterly financial reports and analysis, annual budget and periodic reforecasts. The Treasurer will chair the Finance Committee and serves as the financial officer of RAPS and member of the Executive Committee on the RAPS board of directors. The Treasurer works with the key RAPS staff to ensure that processes and records of the organization are in accordance with appropriate accounting and financial standards for an association and aligned with the goals and objectives established by the board.
Directors
Directors, along with the officers, are responsible for identifying strategic opportunities and directions RAPS and the profession, assuring the operational integrity and effectiveness of the organizations, developing policies, and promoting and representing RAPS and the profession. Directors serve a three year term and may be re-nominated to a second term.
Directors must have demonstrated regulatory expertise and experience and be able to identify and articulate opportunities for the profession and RAPS. Directors should be able to contribute to developing strategic directions of the organizations as well as assessing the effectiveness of operations and finances.