Joseph Myers

• Create regulatory strategies with cross functional teams to meet international regulatory needs driven by product innovation and corporate goals. • Prepare regulatory review of product formulations. Reviews include evaluating chemicals for safety and regulatory compliance with U.S. and international regulations. • Provide assessments and present opportunities for alternative raw materials. • Evaluate feasibility of raw materials against customer’s restricted substances lists such as CLEAN Sephora and ULTA’s Conscious Beauty programs. • Prepare product notification or pre-market approval submissions in 100 markets for new product launches. • Support each distributor on a case-by-case basis to address product registrations, custom requirements, and negotiations with ministries of health in each respective country. • Prepare product information files (PIF), technical information files for toxicological review and safety assessments as needed. • Coordinate external testing and document preparation for product safety (i.e., HRIPT, Patch Test, Preservative Efficacy Testing, Heavy Metals, etc.) • Review labels, claims and marketing collateral and approval as needed. • Monitor marketplace for trends that are outside of regulation (i.e., sulfate-free, non-GMO, etc.) • Provide on-going support to all levels of departments, not limited to Research and Development, Product Development, Marketing, and/or Sales to facilitate required projects. • Manage process for GHS compliant Safety Data Sheets.

• Responsible for developing and implementing regulatory and quality assurance strategies and oversight programs. • Provide regulatory support for all house and private label brands (customers). • Responsible for long- and short-term planning and directing of regulatory/quality activities. • Prepare company readiness for FDA (OTC Drugs) 21 CFR 210 and 211, ISO 22716, SA8000 and customer regulatory certifications and cGMP inspections. • Developed, Implemented, and administration/maintenance of Quality Management System meeting applicable compliance requirements and Regulatory Agencies with respect to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). • Review all product Ingredient list for label/labeling, claims and marketing collateral for In-House and Private Label brands. • Developed and Implemented health and safety plans in the workplace according to OHSA and Workman Compensation requirements. • Evaluate safety practices, procedures, and facilities to assess health and safety risk and adherence to the law. • Provide training and enforce policies to establish a culture for Good Manufacturing Practices, Health and S • safety.

• Managed and coordinated quality assurance programs designed to ensure continuous quality improvement. • Coordinate and maintained all internal, third-party clinical testing and consumer perception studies for all products. • Approved new product development formulations and create harmonized ingredient lists for the global market. • Approve all raw materials, product bulk and filled finished product to ensure they meet specification • Organize, plan, and execute all state, federal and international product registration, and notification activities • Review and approve all product labels and marketing material for all cosmetic and over-the-counter drug products ensure compliance with domestic and international regulatory bodies. • Assessed existing and potential overflow contract manufacturers to ensure they can provide the necessary support and documentation to meet all domestic and international regulatory requirements. • Kept all relevant administrative records up to date.

•Assumed newly created company regulatory position, with oversight of all regulatory requirements for new and existing consumer and cosmetic products for North America and over 100 international markets (EU, Brazil, Korea. Australia, Thailand, Japan, Dubai). •Submitted new product registrations while maintaining product Ecatalogues and Worldwide Environmental Regulatory Compliance Systems (Wercs) for all domestic professional distributors, chain accounts, national retail and TV shopping networks such as QVC and HSN. •Coordinated and maintained all internal and third party testing for product safety and claims substantiation for products as required by the FDA, CPSC, FTC and FCC as well as state level requirements. •Created and maintained submission process for international product registration and notifications to each country’s respective Ministry of Health and Poison Control Centers. •Responsible for creating product ingredient lists and reviewing all product label/labeling and marketing collateral to ensure they are compliant and meet all applicable regulations. •Worked cross functionally with Product Development, Marketing, Sales and Graphics teams on new project initiatives to strategically meet ongoing business demands to deliver quality products that are globally compliant. •Coordinated and implemented internal processes as well as provide training to others to ensure state, federal and international regulatory compliance for Cosmetics and Consumer products are met. •.Review and maintain documentation for all incoming raw materials, new packaging, and product accessories. •.Good Manufacturing and Laboratory Practices ISO 22716 for Cosmetics. •Author, maintain and control the flow of Safety Data Sheet (SDS) for all finished products in US/Canada & EU formatting. •Support and serve as regulatory expert to the Legal Department on all legal matters as they relate to product safety, personal injury, product defects, and counterfeiting.

• Developed and implemented test methods to verify product integrity for production shipment and end use • Accurately conducted root-cause failure analysis, develop action plans, and implemented to eliminate repeat failures • Interfaced with Manufacturing, I&D, Sales and Engineering teams and to assure consistency in product quality • Maintained and ensured compliance with OSHA, EPA, ISO, and site standards • Served as the SPA in Near Miss, Permit to Work and Exposure Monitor reporting Research and Development Chemist • Formulated and modified products to meet requirements specified on product development charters • Evaluated alternative sources for current raw materials and additives for cost engineering of finished products • Maintained accurate and comprehensive laboratory records to ensure documentation of reformulated products for Technical, Operations, and Marketing personnel • Prepared product documentation, product formulations, blending procedures, QC specifications, packaging requirements and Material Safety Data (MSD) Sheets • Addressed issues of batch production and quality control problems for nonconforming materials and out of spec batches