JOSEPH MYERS
Dallas,Texas
Summary
Strategic regulatory leader with extensive experience in the personal care and OTC drug industries. Proven ability to navigate complex regulations, enhance compliance, and drive operational performance through effective team management and cross-functional collaboration. Committed to developing policies and educational programs that align with company goals and ensure adherence to Good Manufacturing Practices.
Overview
28
28
years of professional experience
Work History
Director of Quality and Regulatory Affairs
Revision, LLC
Irving, Texas
06.2023 - Current
- Constructed comment letters to address compliance issues, leading regulatory efforts and ensuring adherence to standards. Engaged in cross-functional collaboration to provide technical assistance for new launches both domestically and internationally. Educated and trained teams on regulatory strategies, enhancing awareness and understanding across functions. Monitored performance of direct reports, providing feedback and setting annual objectives for continuous improvement. Reviewed product claims in copy for accuracy, collaborating with marketing teams to ensure compliance and integrity of messaging. Managed timelines for deliverables during new product launches, keeping project managers informed of progress. Attended aesthetic conferences to remain knowledgeable about industry trends and developments. Conducted out-of-specification investigations and compliance audits.
- Developed quality assurance programs to enhance product reliability and compliance.
- Led cross-functional teams to implement continuous improvement initiatives across operations.
- Conducted regular audits to ensure adherence to quality standards and regulatory requirements.
Regulatory Consultant
Various Clients
, US and EU
01.2022 - 06.2023
- Identify domestic and international regulatory requirements and conduct related analyses to support client new product innovation base business implementation, market access and post-marketing related activities.
- Facilitated preparation of administrative and technical documentation for domestic and international regulatory product registration submissions, ensuring compliance with regulations and supporting post-market compliance maintenance.
- Reviewed formula, product ingredient list, claims, and all labeling/marketing collateral for cosmetic, OTC drug, and consumer products, ensuring domestic and international compliance and mitigating regulatory risks.
- Created EU product information files (PIF) and technical information files for toxicological review and product safety assessments, enhancing product safety and regulatory alignment.
- Implement Good Manufacturing Practices according to FDA 21 CFR 210 and 211 and ISO 22716. Write Standard Operating Procedures and Work Instructions to streamline quality system and support GMP.
- Work with third-party testing labs to ensure all grooming appliances meet product safety and regulatory requirements according to the Consumer Product Safety Commission.
Regulatory Affairs Manager
OLAPLEX, INC.
Santa Barbara, CA
01.2020 - 01.2022
- Prepared product notification or pre-market approval submissions in 100 countries for new product launches.
- Created regulatory strategies with cross functional teams to meet international regulatory needs driven by product innovation and corporate goals.
- Reviewed raw materials and formulations product formulations for safety and regulatory compliance with domestic and international regulations.
- Created EU product information files (PIF), technical information files for toxicological review and safety assessments.
- Coordinated external testing and document preparation for clinical testing for pre-market evaluation, claim substantiation and product safety (i.e., HRIPT, Patch Test, Preservative Efficacy Testing, Heavy Metals, etc.).
- Evaluate feasibility of raw materials against customer's restricted substances lists for CLEAN Beauty Programs such as CLEAN Sephora and ULTA's Conscious Beauty programs.
- Supported distributors in addressing product registrations, custom requirements, and negotiations with ministries of health across multiple countries.
- Managed GHS compliant Safety Data Sheets process to ensure regulatory compliance and product safety.
Director of Regulatory and Quality Compliance
CHEMCO CORPORATION
Miami Gardens, FL
01.2016 - 01.2020
- Developed and implemented regulatory strategies and oversight programs while advising on the regulatory pathway for product registration, manufacturing, product development, operations, and testing programs for OTC drugs and cosmetics.
- Planned and directed regulatory activities to align with long- and short-term strategic initiatives.
- Implemented Good Manufacturing Practices according to FDA 21 CFR 210 and 211 and ISO 22716 for cosmetics.
- Wrote 300 Standard Operating Procedures and Work Instructions to meet FDA, ISO, USP and ICH guidelines.
- Served as primary interface for FDA, ISO 27716, and customer audits, ensuring compliance and facilitating communication.
- Lead investigation activities, perform root-cause analyses and develop corrective and preventative action plans.
- Developed and implemented health and safety plans in the workplace according to OHSA and Workers' Compensation requirements.
- Developed and managed core training programs and policies to establish a culture for Good Manufacturing Practices and Health and Safety.
Regulatory and Quality Compliance Manager
DS HEALTHCARE GROUP, INC
Pompano Beach, FL
01.2015 - 01.2016
- Organized, planned, and executed all state, federal and international (35 markets) product registrations, notifications and submissions.
- Approved raw materials and finished products to ensure compliance with specifications and regulatory standards.
- Reviewed and approved product labels and marketing materials to ensure adherence to domestic and international regulatory requirements.
- Coordinated internal and third-party clinical testing and consumer perception studies to validate product efficacy and market acceptance.
- Managed and coordinated quality assurance programs designed to ensure continuous quality improvement.
- 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.
- Reviewed and approved new product development formulations and created harmonized ingredient lists for the global market.
- Kept all relevant administrative records up to date.
Regulatory Compliance Manager
FAROUK SYSTEMS, INC.
Houston, TX
01.2009 - 01.2015
- Developed and implemented regulatory strategies to meet regulatory requirements and manage the product lifecycle for all new and existing products.
- Reviewed and approved product formulations, labels, and marketing collateral to ensure compliance with regulatory standards.
- Coordinated internal and external testing for product safety and claims substantiation, adhering to FDA, FTC, FCC, CPSC, Prop 65, CARB, and state requirements.
- Created and maintained product submissions for state, national, and international registrations and notifications, ensuring timely market access.
- Worked closely with the product development and marketing teams to incorporate all regulatory requirements and standards from concept to product launch.
- Created EU product information files (PIF), technical information files for toxicological review and safety assessments.
- Worked closely with and provided ongoing support to the company's sales team and international distributors to ensure proper market access.
- Implemented Quality Management System meeting applicable compliance requirements for ISO 22716 Good Manufacturing Practices (GMP).
- Worked with third-party testing labs to ensure all grooming appliances meet product safety and regulatory requirements.
- Supported and served as regulatory expert to the Legal Department on all legal matters.
- Managed a team of four (4) employees.
Product Integrity Champion
BP NORTH AMERICA
Naperville, IL
01.2003 - 01.2008
- Developed and implemented test methods to verify product integrity for production shipment and end use.
- Accurately conducted root-cause failure analysis, developed action plans, and implemented to eliminate repeat failures.
- Collaborated with manufacturing, I&D, sales, and engineering teams to ensure product quality consistency.
- Ensured compliance with OSHA, EPA, ISO, and site standards to uphold safety and quality benchmarks.
- Acted as subject matter expert for Near Miss, Permit to Work, and Exposure Monitor reporting processes, enhancing reporting accuracy.
Product Development Engineer
D.A. STUART Specialty Chemical Company
Warrenville, IL
01.1999 - 01.2001
- Developed formulations and engineered value for new and redesigned coolants, lubricants, and rolling oil products, enhancing product performance.
- Executed laboratory procedures and testing methods, conducting physical and analytical tests on in-process and final products to ensure quality standards.
- Identified production issues and implemented corrective actions to enhance batch production and quality control in manufacturing and R&D.
- Delivered technical assistance at customer facilities.
Education
B.S. - Chemical Engineering
Iowa State University
Ames, IA01-1998
Skills
- Regulatory compliance
- Regulatory leadership
- Regulatory framework
- Regulatory research
- Manufacturing practices
- Project management
- Cross-functional collaboration
- Root cause analysis
- Innovative problem-solving
- Strategic thinking
- Detail-oriented
- Decision making
Accomplishments
- Assumed newly created regulatory position for a major professional hair care and consumer product company with successful implementation in company's organizational structure.
- Provided valuable global corporate strategy as it relates to regulation requirements, product registration and market access for new and existing cosmetic and OTC drug products for North America and over 100 international markets.
- Maintained product regulatory e-catalogues and Worldwide Environmental Regulatory Compliance Systems (Wercs) for all domestic professional distributors, retail chain and direct to consumer accounts such as Sephora, Ulta, Kohls, Nordstrom, Regis, QVC, HSN and Amazon.
- Authored and/or maintained and controlled the flow of Safety Data Sheet (SDS) for all finished products in US/Canada & EU GHS formatting.
- Established quality assurance programs and conducted audits on all contract manufacturers to ensure Good Manufacturing Practices.
- Successfully implemented ISO 22716 Good Manufacturing Practices for Cosmetics
Academic And Professional Qualifications
B.S. Chemical Engineering, 08/93 - 05/98, Iowa State University, Ames, IA
Highlighted Competencies
- Authentic Leadership: Inherent, impassioned, and revered
- Demonstrated ability to work with and support cross-functional project teams
- Project Management: Ability to manage multiple projects simultaneously and under pressure.
- Strong attention to detail and focus on task completion.
- Strategic Thinking: Creative committed visualization accessible to all
- Innovative Thinking: Create new ideas to improve our global customers supply chain
- Investigating and determining the cause of irregularities and errors.
- Proven ability to consistently make the right decisions and judgments.
- Highly developed research skills.
Timeline
Director of Quality and Regulatory Affairs
Revision, LLC
06.2023 - Current
Regulatory Consultant
Various Clients
01.2022 - 06.2023
Regulatory Affairs Manager
OLAPLEX, INC.
01.2020 - 01.2022
Director of Regulatory and Quality Compliance
CHEMCO CORPORATION
01.2016 - 01.2020
Regulatory and Quality Compliance Manager
DS HEALTHCARE GROUP, INC
01.2015 - 01.2016
Regulatory Compliance Manager
FAROUK SYSTEMS, INC.
01.2009 - 01.2015
Product Integrity Champion
BP NORTH AMERICA
01.2003 - 01.2008
Product Development Engineer
D.A. STUART Specialty Chemical Company
01.1999 - 01.2001
B.S. - Chemical Engineering
Iowa State University