Director, Regulatory Affairs at Amneal Pharmaceuticals
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I am a senior pharmaceutical regulatory professional with more than 20 years of experience leading FDA‑facing regulatory strategy, Chemistry, Manufacturing, and Controls (CMC), and post‑approval lifecycle management for complex drug products. I currently serve as Director of Regulatory Affairs (CMC) at Amneal Pharmaceuticals of NY LLC, where I am responsible for defining and executing CMC regulatory strategies for NDAs, ANDAs, prior‑approval supplements, and other complex regulatory submissions.
In my role, my regulatory recommendations are relied upon to resolve complex compliance issues, support FDA approvals, and ensure continuity of supply for critical medicines. I have played a key role in advancing programs of significant public‑health importance, including products associated with emergency preparedness and government stakeholders. In multiple instances, I have engaged directly with FDA reviewers through formal meetings to address scientific and regulatory questions and to expedite approval timelines.
