Jenny Brooks
Director of Regulatory Affairs @ USANA Health Sciences
About
As a proactive leader in Regulatory & Compliance, I specialize in clearing obstacles and minimizing long-term risks for organizations. With hands-on experience in over 25 markets, I not only shape regulatory strategies but also mentor global teams to navigate complex challenges and provide multiple solutions. Through strategic collaboration, I’ve accelerated speed-to-market initiatives by 75%. My expertise spans life sciences, market regulation research, quality systems, product legalization, and defending marketing claims with a sharp focus on dietary supplements, foods, skincare, sports nutrition, nutraceuticals, OTCs, and their global counterparts. I ensure organizations not only meet compliance but excel in commercializing products worldwide.
United States
Lehi
Food Production
Regulatory Affairs, Risk Analysis, Regulatory Submissions, Quality System, Business Strategy, Marketing Strategy, Regulatory Requirements, Nutraceuticals, Diversity, Equity, and Inclusion Training, Mentoring, 21 CFR, Communication, Employee Relations, Technical Documentation, U.S. Food and Drug Administration (FDA), Strategic Thinking, Product Development, Lean Management, Interdepartmental Relations, Staff Development
Experience

Director of Regulatory Affairs
Salt Lake City Metropolitan Area
Led a team of regulatory professionals supporting a 24/7 operation for an organization with more than $1B in annual revenue across 25 global markets. Primary contact and regulatory head representing Nutraceuticals across all 25 markets, and all product classifications for 12+ Asia Pacific markets. Representative in trade associations, and with internal/external stakeholders, and business interests. ➢ Created the product risk mitigation program based upon financial impact, delivering quantifiable data-driven tools resulting in a coordinated and collaborative executive effort. ➢ Primary contact for the organization in trade associations and with internal/external stakeholders, and business interests. ➢ Streamlined and monitored a record-breaking 1600 regulatory projects across all Asia Pacific in real-time, resulting in compliant audit outcomes and cutting product development time by 30%. ➢ Led regulatory affairs individuals through a transformation project maintaining all nutraceutical classifications across 25 markets. Increased speed of communication among sister departments by 15% ➢ Mentored staff by discussing new trends and regulatory enforcements, created a consistent and equitable atmosphere.

Manager of Product Systems
Salt Lake City Metropolitan Area
Developed and mentored a team of 9 Quality and Regulatory Systems professionals spearheading continuous improvement initiatives across 3 global manufacturing sites. ➢ Improved costs and speed by establishing quality processes and regulatory systems accelerating technical implementations from 6 months to 3 months, this resulted in increased sales and product launches. ➢ Developed a label compliance system resulting in 30% fewer mistakes and a decrease in review cycles by 20% ➢ Cultivated a compliant marketing claims library for over 500 SKUs, achieving substantiated product claims alignment between internal departments and compliant individual distributor websites.

Senior Regulatory & Quality Systems Analyst
United States
Managed global systems for product development, and regulatory affairs and quality systems. ➢ Anticipated government action and led the internal audit of 245 products in Australia, China, Canada, Korea, and the United States. Batch product records (BPRs), registered formula, tablet specifications, and product labels were verified or amended resulting in passing future applicable audits. ➢ Streamlined and unified the formula review process under the Oracle Agile Product Governance and Compliance module. This cut consulting costs by 55%, while increasing speed of formula compliance review by 75%. ➢ Pioneered the capture of Gantt charts for 80 registration pathways globally, simultaneously crafting 80 compliant product label templates in multiple classifications/markets. This resulted in setting the regulatory standard.

Senior Regulatory Affairs Specialist
United States
Performed the technical global regulatory affairs function for Southeast Asia producing compliant product registrations and positions with foreign governments. Launched the Halal and Kosher certification and compliance program including the auditing of multiple facilities. ➢ Conducted technical regulatory work, including product registrations, marketing claims compliance, and formula development across various regions specializing in Southeast Asian Markets. ➢ Researched and performed all key regulatory tasks for Indonesia market opening. ➢ Regulatory engagement liaison inspiring collaboration between Marketing, RD, Quality, and Regulatory Affairs resulting in an atmosphere of anticipating compliance and achieving manufacturing excellence.
Jenny Brooks's Contact Information
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