Angela is a business-centric, resolutions-oriented, regulatory compliance-driven corporate attorney with extensive cross-functional regulatory and legal leadership and project management experience. She has a substantial U.S. Food and Drug Administration and Federal Trade Commission legal and regulatory review portfolio, specifically in pre-market and post-market legal and regulatory submissions strategy and gap analyses; marketing and labeling reviews; civil and criminal litigation matters; and compliance and enforcement analysis and strategy development interpreting the Food, Drug, and Cosmetic Act (FDCA), the Family Smoking Prevention and Tobacco Control Act (TCA), Federal Cigarette Labeling and Advertising Act (FCLAA), Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Administrative Procedure Act, Paperwork Reduction Act, and their implementing regulations and guidances.
She has experience with global notifications and submissions including Tobacco Products Directive and Medicines and Healthcare products Regulatory Agency (MHRA) submission strategy, in addition to FDA Supervisory Review, scientific and litigation strategy development, including emergency stays. She also has extensive experience in Quality Systems development and improvement projects, and prior experience in antitrust merger investigations and second requests pursuant to Hart-Scott-Rodino (HSR) Act. Experience as judicial clerk for two state court judges, specifically in civil and family litigation.
Posted in Who’s Who at EAS.