WASHINGTON--(BUSINESS WIRE)--Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA or Agency) regulatory consulting firm providing strategic and technical guidance to pharmaceutical and medical device companies, announces that Kalah Auchincloss, JD, MPH, has joined the firm as Senior Vice President, Regulatory Compliance and Deputy General Counsel.
Kalah brings more than a decade of food and drug legal, policy, and regulatory experience to her roles at Greenleaf. Most recently, Kalah spent six years at FDA as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Kalah’s experience also includes time as an associate at the law firm Foley Hoag LLP, in the firm’s healthcare practice group. Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University. Kalah will provide regulatory advice to Greenleaf clients in her role as Senior Vice President, and will also be part of the team managing Greenleaf’s legal affairs in her role as Deputy General Counsel.
In addition to Kalah’s arrival at Greenleaf, the firm is also pleased to announce that two long-time employees will assume new roles. Maura Norden, J.D., currently Senior Vice President, Medical Devices and Combination Products, has been named General Counsel and will now also manage Greenleaf’s legal affairs. Maura joined Greenleaf in 2015 from the law firm Sidley Austin LLP, following nearly a decade of experience advising leading medical device and drug companies on a broad range of FDA regulatory matters. Maura will continue to provide regulatory guidance to Greenleaf’s clients.
Also assuming a new role, Kathleen Sonntag has been promoted to Chief Operating Officer (COO) for Greenleaf. Kathleen joined the firm in 2011 and most recently served as Greenleaf’s Chief Financial Officer (CFO). Kathleen’s broad career experience spans financial services and the legal profession, with an emphasis on information technology and data analysis. This unique blend brings strong analytical, technical and business skills to her role at Greenleaf.
About Greenleaf Health
Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. With a team of experts with more than 200 years of FDA experience, Greenleaf provides a wealth of experience that is unmatched.
For more information on Kalah Auchincloss, Maura Norden, Kathleen Sonntag and Greenleaf Health, visit greenleafhealth.com.