Director of Regulatory
CoreFX Ingredients, Madison, WI, United States
CoreFX Ingredients is a US-based manufacturer specializing in innovative powdered lipid, dairy-based, and bioactive shielded bio-transport technologies that deliver on efficacy, stability, and functionality. With facilities in Orangeville, IL and Big Bend, WI, and headquartered in Evanston, IL, CoreFX advances nutrient optimization through proprietary delivery systems designed to enhance transport, protection, release, absorption, and performance in food, beverage, and dietary supplement applications.
Our expertise spans microencapsulated lipids, functional dairy systems, and next-generation nutrient delivery platforms engineered to improve bioavailability, oxidative stability, sensory performance, and processing resilience. From omega-rich powdered lipids and specialty fat systems to protein-integrated bioactives and controlled-release solutions, CoreFX develops ingredient technologies that solve complex formulation challenges while driving measurable efficacy.
Our mission is to create and lead customer- and performance-inspired, service-driven, authentic, and effective shielded bio-transport and functional ingredient technologies for success. We achieve this by engineering systems that optimize nutrient and bioactive performance, stability, and controlled release — guided by creativity, clarity, integrity, and an entrepreneurial spirit.
JOB PURPOSE AND REPORTING STRUCTURE The Director of Regulatory is responsible for developing and executing regulatory strategies that ensure compliance with global food safety and regulatory requirements for specialized food ingredients. This role oversees regulatory compliance, labeling, documentation, and customer regulatory support while guiding internal teams through evolving regulatory landscapes. The Director will work cross-functionally with Quality, R&D, Sales, Operations, and Supply Chain to ensure all finished products and raw materials meet regulatory requirements and customer expectations across domestic and international markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES Regulatory Strategy & Compliance
Develop and lead regulatory strategies to ensure compliance with FDA, USDA, FSMA, and international regulatory requirements (including but not limited to Health Canada, EFSA, etc.)
Interpret and implement regulatory requirements impacting specialized food ingredients, additives, and functional ingredients.
Monitor and communicate changes in regulatory frameworks affecting the food ingredient industry.
Provide regulatory guidance during new product development and commercialization.
Documentation & Regulatory Submissions
Oversee preparation and maintenance of regulatory documentation including:
Ingredient statements
Qualified Health and Functional Claims
Regulatory compliance letters
Technical data sheets
Allergen statements
Non-GMO statements
Organic compliance documentation
Manage regulatory submissions such as GRAS notifications, food additive petitions, and international ingredient approvals where applicable.
Labeling & Customer Regulatory Support
Provide expertise on ingredient labeling, claims, and compliance with FDA and international regulations.
Respond to customer regulatory questionnaires and documentation requests.
Support commercial teams by ensuring regulatory compliance for marketing and product claims (health, structure/function claims).
Review and validate technical dossiers and clinical data to support bioavailability and performance-related claims for both food and supplement markets.
Cross-Functional Leadership
Partner with R&D, Quality, Operations, and Sales to ensure regulatory requirements are integrated into product development and manufacturing processes.
Serve as the internal subject matter expert on food and dietary supplement regulatory matters.
Lead regulatory risk assessments and mitigation strategies.
Global Regulatory Oversight
Ensure regulatory compliance for ingredient distribution in key markets including North America, EU, Canada, and other global regions.
Manage and oversee Novel Food Applications (Regulation (EU) 2015/2283) to ensure market access for innovative delivery systems and bioactives in the EU.
Coordinate with international regulatory consultants or agencies as needed.
Team Leadership
Build, manage, and mentor the regulatory affairs team.
Establish regulatory processes, documentation systems, and training programs.
QUALIFICATIONS
Bachelor’s or Master’s degree in Food Science, Chemistry, Regulatory Affairs, Microbiology, or related scientific field.
10+ years of experience in regulatory affairs within the food or food ingredient industry.
Experience with specialized or functional food and dietary supplements ingredients preferred.
Demonstrated knowledge of FDA regulations (including CFR Title 21 parts 111, 117, and 101, FD&C Act, DSHEA, FSMA, FPLA), and GRAS processes.
Experience managing regulatory documentation and customer regulatory support.
Specific experience navigating EFSA health claim substantiation and European food additive regulations.
Deep understanding of food ingredient regulatory frameworks.
Strong leadership and team management skills.
Excellent written and verbal communication abilities.
Ability to translate complex regulatory requirements into practical business guidance.
Strong cross-functional collaboration and project management skills.
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Our expertise spans microencapsulated lipids, functional dairy systems, and next-generation nutrient delivery platforms engineered to improve bioavailability, oxidative stability, sensory performance, and processing resilience. From omega-rich powdered lipids and specialty fat systems to protein-integrated bioactives and controlled-release solutions, CoreFX develops ingredient technologies that solve complex formulation challenges while driving measurable efficacy.
Our mission is to create and lead customer- and performance-inspired, service-driven, authentic, and effective shielded bio-transport and functional ingredient technologies for success. We achieve this by engineering systems that optimize nutrient and bioactive performance, stability, and controlled release — guided by creativity, clarity, integrity, and an entrepreneurial spirit.
JOB PURPOSE AND REPORTING STRUCTURE The Director of Regulatory is responsible for developing and executing regulatory strategies that ensure compliance with global food safety and regulatory requirements for specialized food ingredients. This role oversees regulatory compliance, labeling, documentation, and customer regulatory support while guiding internal teams through evolving regulatory landscapes. The Director will work cross-functionally with Quality, R&D, Sales, Operations, and Supply Chain to ensure all finished products and raw materials meet regulatory requirements and customer expectations across domestic and international markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES Regulatory Strategy & Compliance
Develop and lead regulatory strategies to ensure compliance with FDA, USDA, FSMA, and international regulatory requirements (including but not limited to Health Canada, EFSA, etc.)
Interpret and implement regulatory requirements impacting specialized food ingredients, additives, and functional ingredients.
Monitor and communicate changes in regulatory frameworks affecting the food ingredient industry.
Provide regulatory guidance during new product development and commercialization.
Documentation & Regulatory Submissions
Oversee preparation and maintenance of regulatory documentation including:
Ingredient statements
Qualified Health and Functional Claims
Regulatory compliance letters
Technical data sheets
Allergen statements
Non-GMO statements
Organic compliance documentation
Manage regulatory submissions such as GRAS notifications, food additive petitions, and international ingredient approvals where applicable.
Labeling & Customer Regulatory Support
Provide expertise on ingredient labeling, claims, and compliance with FDA and international regulations.
Respond to customer regulatory questionnaires and documentation requests.
Support commercial teams by ensuring regulatory compliance for marketing and product claims (health, structure/function claims).
Review and validate technical dossiers and clinical data to support bioavailability and performance-related claims for both food and supplement markets.
Cross-Functional Leadership
Partner with R&D, Quality, Operations, and Sales to ensure regulatory requirements are integrated into product development and manufacturing processes.
Serve as the internal subject matter expert on food and dietary supplement regulatory matters.
Lead regulatory risk assessments and mitigation strategies.
Global Regulatory Oversight
Ensure regulatory compliance for ingredient distribution in key markets including North America, EU, Canada, and other global regions.
Manage and oversee Novel Food Applications (Regulation (EU) 2015/2283) to ensure market access for innovative delivery systems and bioactives in the EU.
Coordinate with international regulatory consultants or agencies as needed.
Team Leadership
Build, manage, and mentor the regulatory affairs team.
Establish regulatory processes, documentation systems, and training programs.
QUALIFICATIONS
Bachelor’s or Master’s degree in Food Science, Chemistry, Regulatory Affairs, Microbiology, or related scientific field.
10+ years of experience in regulatory affairs within the food or food ingredient industry.
Experience with specialized or functional food and dietary supplements ingredients preferred.
Demonstrated knowledge of FDA regulations (including CFR Title 21 parts 111, 117, and 101, FD&C Act, DSHEA, FSMA, FPLA), and GRAS processes.
Experience managing regulatory documentation and customer regulatory support.
Specific experience navigating EFSA health claim substantiation and European food additive regulations.
Deep understanding of food ingredient regulatory frameworks.
Strong leadership and team management skills.
Excellent written and verbal communication abilities.
Ability to translate complex regulatory requirements into practical business guidance.
Strong cross-functional collaboration and project management skills.
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