Regulatory Compliance Manager- Product Testing
Tucson based Consumer Packaged Goods manufacturer is seeking an experienced Regulatory Compliance Manager to plan, coordinate, and direct the quality assurance and regulatory affairs program to ensure quality production of products consistent with established standards and that all product meet critical regulatory requirements as well. The incumbent will manage all regulatory compliance aspects of business, including ensuring formulas and packaging are compliant with regulations in countries in which products are sold, registering new products with necessary organizations, and overseeing product testing and quality assurance.
He or she will work closely with product development, packaging, operations, and finance/legal, as well as outside advisers.
The successful candidate will have significant experience in regulatory affairs, ideally in the Beauty or CPG industries, and be detail-oriented and self-motivated.
· Formulates and maintains quality assurance objectives complementary to corporate policies and goals.
· Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
· Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
· Decides whether to accept a product or continue business with a vendor based on a review by the quality assurance engineer.
· Reviews all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.
· Develops new approaches to solve problems identified during quality assurance activities.
· Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
· Prepares and presents technical and program information to the management team.
· Directs technical and administrative workers engaged in quality assurance activities.
· Maintains a working knowledge of government and industry quality assurance codes and standards.
· Plays an active role on quality management teams within the organization.
· Designs and implements quality assurance training programs to key personnel in conjunction with managers.
· Investigates and adjusts customer complaints regarding quality.
· Is responsible for the overall direction, coordination, and evaluation of the Quality Department.
· Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
· Act as subject matter expert on regulatory affairs, safety and quality assurance
· Understand and manage formula and packaging compliance with US (e.g., California labeling guidelines) and international regulations for new and existing products
· Stay up to date with regulatory changes impacting ingredients and products and communicate developments to management and formulators.
· Ensure all product formulas/raw materials are in compliance with domestic and international regulatory and environmental regulations, including REACH
· Obtain cosmetic free sales certificates
· Manage international regulatory filings and necessary updates to regulatory filings in each market
· Generate ingredient lists for labeling of new products
· Help field consumer inquires and manage ingredient FAQ's
· Perform artwork/label review
· Consult on claims language
· Ensure packaging is in compliance with global regulations
· Compile documentation and maintain European regulatory Product Information Files for each product.
· Recommend and oversee quality assurance programs
· Oversee product safety and stability testing (Micro, safety, HRIPT)
· Manage US FDA registration, drug establishment, labeler code submissions and voluntary cosmetic reporting for Drug/SPF products
· Manage California safe cosmetic reporting
· Author SDS's
· Advocate for the company with industry associations
· Act as primary point of contact and liaison for internal teams, vendors and regulatory representatives, MOH, etc.
· Advise on clinical and consumer science trials
Supervisory responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
· Minimum 7 years’ experience in regulatory affairs and or quality management role in a CPG manufacturing and sourcing environment.
· Minimum 2 years leading a strategic regulatory or quality organization driving systems, processes, and products
· Minimum Bachelor’s Degree from an accredited Institution
· Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.
· Strong understanding of global CPG regulations to support sourcing activities
· Extensive knowledge of safety regulations and industry standards relating to a variety of consumer products in the US, EU, and Canada
· Product development experience a plus
· Established industry relationships a plus
· Excellent verbal & written communication and organizational skills mandatory
· Extremely detail-oriented
· Strategic thinker who blends strong analytics and creativity and curiosity
· Strong work ethic and can-do attitude
· Problem solving and entrepreneurial in nature
· Ability to manage multiple projects and priorities simultaneously
· Strong team player
· Thrive in a fast-paced entrepreneurial environment
· 8+ years of industry experience in including hair care, beauty, and/or CPG experience
· Experience with and knowledge of lean management tools.
· Quality Engineering certification (ASQ, CQE, CQA)