Jennifer Ekelund
President, Ekelund Consulting
Jennifer Ekelund has over 25 years of industry experience in drug development across a broad range of therapeutic areas. Her experience ranges from early and late stage development for marketing approvals to post-approval lifecycle management and marketing activities. This work has included pediatric and orphan designated products, subpart H approvals, single and shared REMS (Risk Evaluation and Mitigation Strategies) programs, interactions with US and international health authorities, FDA inspections, formal dispute resolution processes with the FDA, as well as DEA interactions for controlled substances and scheduled products.
During her time at Alza Corporation (1991 – 2004), Ms. Ekelund worked primarily in Regulatory Affairs and Compliance roles, contributing to the marketing approvals of multiple products. She joined Jazz Pharmaceuticals in 2004 to build their Regulatory Affairs department. While at Jazz (2004-2018), she held leadership positions in Regulatory Affairs and Clinical Quality Assurance, supporting the development and commercialization of multiple products, and provided advice on the evaluation of assets for potential licensing and acquisitions.
Ms. Ekelund began consulting (Ekelund Consulting) in 2018, providing Regulatory and Quality consultation and services to several small and midsized biopharmaceutical companies, primarily in the San Francisco Bay Area.
Ms. Ekelund holds a B.A. in International Relations from Boston University.