Regulatory and Quality guru. Extensive knowledge in global food, cosmetic, and dietary supplement laws and regulations. Food safety and quality expert. Effective strategist and creative problem solver. Team player, trainer, and strong negotiator. Labeling, advertising, consumer protection. FTC, FDA, USDA, EU, N. America, LATAM, APAC, Asia, Russia, AU/NZ expansion. Risk analysis and strategic risk reduction.

Oversee all regulatory, research and development, substantiation, and compliance activities for the nutritional arm of Dr Reddy's Laboratories.

Directed regulatory functions and served as regulatory expert for multidisciplinary global expansion team for POM Wonderful, Paramount Farms, and Fiji Water; novel food compliance, POM v FTC discovery and litigation, FDA inspections, consumer protection regulations, labeling, marketing and advertising compliance, scientific substantiation review, GMP regulations, product registration, FDA and CBP import detention negotiation.As the primary company advisor for the Food Safety Modernization Act (FSMA), represented companies and pistachio industry in developing FSMA comments to the FDA on behalf of the tree nut, fruit juice, and fresh produce industries. Developed a FSMA compliance strategy for the Wonderful companies, including conducting FSMA compliance audits.

Participated in committee meetings to develop strategy to address legislative and scientific actions that threatened or may have influence over regulation or perception of global tree nut and dried fruit industry.

Develop strategy and responses to scientific publications related to fruit juice consumption, USP standards, FSMA, proposed nutrition facts labeling changes, dietary guidelines committee reports, and other matters.

Participated in strategy meetings to discuss industry and government activities that may affect the juice industry. Develop strategy and responses to FSMA, proposed US and Canadian nutrition facts labeling changes, dietary guidelines committee reports, and other matters.

Represented Paramount Farms in a trade group with the Almond Board of California, California Walnut Board, Dried Fruit Association, Administrative Committee for Pistachios, Frucom, International Nut and Dried Fruit Council, USDA Foreign Agricultural Service, US EPA.Participated in industry negotiation sessions to develop a cross-industry diplomatic strategy to negotiation with DG-SANCO and the European Commission to expand authorized uses of a pesticide often associated with tree nuts and dried fruit.

Represent pistachio industry in negotiations with FDA regarding the tree nut risk assessment.Engaged in brainstorming sessions with other major tree nut industry members to develop strategy for coordinating tree nut risk assessment with the FDA.

Participated in strategy meetings and negotiated with other industry members to develop comments to submit to the FDA in response to published proposed FSMA rules.

Participated in industry association coordination meetings to develop strategy for research, diplomatic efforts, regulatory responses, and other matters facing the almond industry.

Oversaw a quality control team to improve cGMP activities through training the quality and production teams, implementing new and revised quality procedures, conducting audits, developing a culture of quality and food safety, building and establishing an in-house quality control and microbiological laboratory.Prepared regulatory documents for clients, advised clients in regulatory compliance matters, and represented company in regulatory inspections.

As a start-up, created the first regulatory and legal compliance department procedures for US and international business activities marketing cosmetics, dietary supplements, natural products, OTC products, and medical devices. Managed legal affairs, including selecting legal representation, obtaining business licenses and import permits, managing global trademark/patent applications, and contract negotiations. Develop regulatory strategy for international compliance throughout North America and Asia. Developed and oversaw Adverse Event Reporting process and consumer complaint responses. Oversaw scientific substantiation of claims, product development and formulation, vendor and contract manufacturing relations, oversee direct selling distributor compliance, respond to non-compliance concerns, and monitor distributor advertising activities.

Manage regulatory team and oversee regulatory projects for hundreds of products, including dietary supplements, natural products, cosmetics, essential oils, and others in over 20 countries in Asia Pacific, Australia, Europe, No. America, and Russia. Develop regulatory strategy for new market development via personal consumption/internet sales of dietary supplements and cosmetic products in the EU and throughout Asia. Interview and hire Regulatory Experts in foreign markets. Conduct risk analysis based on regulations and enforcement actions.Maintain current industry knowledge through market research and updates on enforcement actions; review safety and efficacy data for proposed formulas; negotiate and help develop regulatory and corporate processes to streamline communications and flow of information throughout corporate expansion team.

Analytical/Problem-solving/Research Experience; Assist in writing presentations for Professors presenting at national and world-wide conventions; Develop research projects for measurement of ambient air conditions and pollution; Author publications and presentations for Air and Waste Management Association; Research measuring technologies to develop new, more efficient technologies;