Have led and provided quality, regulatory, auditing, licensing, governmental relations, and compliance direction, and collaboration with the Executive, Legal, Regulatory, Quality, Operations, Business & Product Development, Business Process Integration, Solutions, and Strategic Partnership teams within companies and reported directly to Executive Management. Directed and managed state and federal processes, registrations, Unique Device Identifiers, National Drug Codes, and reporting related to regulated products, facilities designated management, and customers, including pharmaceuticals, OTC drugs, medical devices, dental care products, animal care products, food, and environmental interaction issues. Advised on statutes regarding the Drug Supply Chain Security Act (DSCSA), Food Safety Modernization Act (FSMA), FDA Title 21 Code of Federal Regulations (CFR), ISO 13485:2016, and ISO 9001:2015. Official liaison with state and federal regulatory agencies such as: FDA, Health Canada, USDA, DEA, National Association of Boards of Pharmacy (NABP), all states Boards of Pharmacy (BOPs), Departments of Public Health, Professional Regulation Agencies, states Environmental Control organizations, and Women’s Business Enterprise National Council (WBENC). Sat as board member of Pharmaceutical Distribution Security Alliance (PDSA) and Device Distribution Uniform Standards Alliance (DDUSA), acting as Subject Matter Expert (SME) in DSCSA regulatory licensing areas to coalition members as well as outside regulatory agencies and Capitol Hill legislative staff members. Led regulatory and advocacy efforts and provided expert advice and consult regarding state and federal regulatory applications, licensing and research matters. Ensured that corporate governance, regulatory and quality contributions and implementations achieved objectives in strategy, monitored and managed filing and post-filing activities, and communicated progress, variance and risk versus benefit impacts to senior and executive management. Provided significant guidance, online course development, and documentation development for implementation of new Regulatory, Quality Management System, current Good Manufacturing Practices (cGMPs), and Auditing/Inspection functions. Acted as key intellectual Subject Matter Expert (SME) in sharing and transfer of Company’s regulatory compliance knowledge during acquisition of one company by new foreign based Owner. Content developer and speaker at multiple state Boards of Pharmacy Meetings, Company webinars and Pharmaceutical/Biopharma (PBOA) global conference.