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Virginia O. Ackerman

Regulatory Strategy and Implementation

Virginia ("Ginger") Ackerman is an expert in all facets of US regulatory affairs, with a track record of success helping US and global healthcare companies develop and implement regulatory approval strategies, new claims, and risk management systems.

With over 25 years experience, Ginger has worked across the broadest range of drug classes and submission types. This includes pharmaceuticals, biotechnology drugs, gene therapy and medical devices as well as consumer products, Rx-to-OTC switches, botanicals, drug/device combinations, and vaccines. Ginger's unique blend of experience, coupled with her proactive, problem-solving approach, has enabled her to provide innovative and results-driven counsel to her healthcare clients.

Before becoming a regulatory consultant in 1995, Ginger served as head of US regulatory affairs (Director, Regulatory Liaison) for Europe-based Solvay Pharmaceuticals. While at Solvay, she reorganized the department and improved productivity, enabling her small staff to complete nearly 400 regulatory submissions, including two major NDAs and four INDs, in just one 12-month period. She also conceived and implemented an electronic model for global registrations, permitting common technical dossiers across countries.

Earlier in her career, she held a range of regulatory leadership positions at Johnson & Johnson and Smith Kline (now GlaxoSmithKline). Supporting both new and established brands, Ginger worked hand-in-hand with Marketing to identify paradigm-changing claims, marshal persuasive technical support, and obtain regulatory approval. Her other accomplishments included: supporting successful Rx-to-OTC switch efforts; obtaining rapid approval for a high-profile orphan drug; managing a Research Quality Assurance unit for GLPs, GCPs, and CGMPs compliance issues including directing FDA inspections in all three areas; and analyzing licensing and acquisition candidates.

Ginger began her pharmaceutical career as a biochemist working in pharmacology, drug discovery and drug metabolism.