Former FDA Senior Official Joins Greenleaf Health

Greenleaf Health Inc. (Greenleaf), a U.S. Food and Drug Administration (FDA) regulatory consulting firm providing strategic and technical guidance to pharmaceutical and medical device companies, announced that Kalah Auchincloss, JD, MPH, has joined the firm as senior vice president, Regulatory Compliance and deputy general counsel.
 
Auchincloss brings more than a decade of food and drug legal, policy, and regulatory experience to her roles at Greenleaf. Most recently, she spent six years at the FDA as deputy chief of staff for FDA Commissioners Dr. Robert Califf and Dr. Scott Gottlieb. As deputy chief of staff, Auchincloss 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.
 
Auchincloss 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, Auchincloss 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.
 
Auchincloss’s experience also includes time as an associate at the law firm Foley Hoag LLP, in the firm’s healthcare practice group. She has 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. Auchincloss 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 Auchincloss’s arrival at Greenleaf, 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. Norden 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. Norden 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. Sonntag joined the firm in 2011 and most recently served as Greenleaf’s chief financial officer (CFO). Her 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.
 
Greenleaf Health is an FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing solutions to pressing global public health challenges. The Washington, D.C.-based company boasts a team of experts with more than 200 years of FDA experience.