Electrolit USA
Position Summary
The Regulatory Affairs Manager serves as a strategic individual contributor responsible for leading and coordinating all regulatory affairs related to Electrolit products across the United States, Canada or markets in EU. This role is pivotal in developing and executing comprehensive regulatory strategies to ensure full compliance with applicable food safety and quality standards, including those set by the FDA, CFIA, and other relevant international frameworks.
Operating cross‑functionally across departments, the Regulatory Affairs Manager manages regulatory documentation, labeling compliance, advertising and serves as the primary liaison with regulatory authorities. The position also supports product development, market access initiatives, and continuous improvement efforts, while proactively identifying regulatory risks and opportunities.
This role maintains strong alignment with the Electrolit Global Regulatory Team to ensure consistency and best practices across markets and collaborates closely with internal and external legal counsel to address regulatory and legal matters.
Location:
HQ, Houston, TX
Responsibilities
Lead regulatory compliance efforts in alignment with GMP, corporate, and international standards (FDA, Health Canada, EFSA, GRAS, CFIA, COFEPRIS, ISO 9001, etc.).
Provide strategic guidance on regulatory impacts of operational changes, supplier updates, and new market entry within the USA and Canada.
Coordinate audit readiness activities, including mock audits and internal inspections, and serve as the primary contact for regulatory inspections and document reviews.
Review product labels, advertising and packaging for regulatory accuracy and compliance with FDA, CFIA, and international labeling standards.
Represent the organization in high‑level discussions with regulatory agencies to resolve compliance matters.
Collaborate with internal and external legal counsel on regulatory and legal issues, including product claims, labeling, and market access.
Advise executive leadership on regulatory implications of marketing claims and ESG initiatives.
Engage with industry forums and regulatory associations to stay ahead of trends and influence policy.
Conduct regulatory risk assessments and ensure integration of compliance requirements in product development.
Implement and manage regulatory tracking systems, compliance matrices, and dashboards to monitor deliverables and performance.
Provide training and guidance to cross‑functional teams on regulatory expectations, documentation practices (ALCOA+ principles), and compliance protocols.
Coordinate document translations and localization for international submissions and multi‑country product launches.
Maintain a repository of regulatory FAQs, templates, and guidance documents to support daily operations.
Report key compliance metrics and strategic risks to senior leadership, recommending mitigation plans.
Perform other duties as assigned to support regulatory and business objectives.
Knowledge, Skills, and Abilities
Strong knowledge of FDA, Health Canada, and international food regulations.
Expertise in GMP, LACF (Low Acid Canned Foods), and labeling standards.
Proficiency in document control systems, compliance tools, and regulatory tracking platforms.
Excellent communication, negotiation, and cross‑functional collaboration skills.
Experience working with legal counsel on regulatory matters.
Strategic thinking, proactive problem‑solving, and adaptability in a dynamic environment.
Ability to lead initiatives and influence outcomes without direct supervisory authority.
Qualifications
Bachelor’s degree in Law, Pharmaceutical Sciences, Chemical‑Biological Sciences, or related fields.
Valid professional license and degree certificate required.
Minimum 7 years in food industry regulatory roles.
Proven experience with FDA, CFIA regulations, and regulatory agency interactions.
Experience with LACF regulations and product registrations in the U.S. and Canada.
Other Requirements
Must be authorized to work in the U.S.
Availability to travel quarterly.
Ability to work flexible hours as needed to support operations.
Spanish advanced
Physical Requirements
Standard office environment.
Ability to attend on‑site audits and inspections.
Occasional travel to regulatory meetings or manufacturing sites.
Cab Enterprises Inc. is committed to maintaining a work environment that promotes diversity and is free of discrimination. Except where prohibited by state law, all offers of employment might be subject of passing a drug test.
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Operating cross‑functionally across departments, the Regulatory Affairs Manager manages regulatory documentation, labeling compliance, advertising and serves as the primary liaison with regulatory authorities. The position also supports product development, market access initiatives, and continuous improvement efforts, while proactively identifying regulatory risks and opportunities.
This role maintains strong alignment with the Electrolit Global Regulatory Team to ensure consistency and best practices across markets and collaborates closely with internal and external legal counsel to address regulatory and legal matters.
Location:
HQ, Houston, TX
Responsibilities
Lead regulatory compliance efforts in alignment with GMP, corporate, and international standards (FDA, Health Canada, EFSA, GRAS, CFIA, COFEPRIS, ISO 9001, etc.).
Provide strategic guidance on regulatory impacts of operational changes, supplier updates, and new market entry within the USA and Canada.
Coordinate audit readiness activities, including mock audits and internal inspections, and serve as the primary contact for regulatory inspections and document reviews.
Review product labels, advertising and packaging for regulatory accuracy and compliance with FDA, CFIA, and international labeling standards.
Represent the organization in high‑level discussions with regulatory agencies to resolve compliance matters.
Collaborate with internal and external legal counsel on regulatory and legal issues, including product claims, labeling, and market access.
Advise executive leadership on regulatory implications of marketing claims and ESG initiatives.
Engage with industry forums and regulatory associations to stay ahead of trends and influence policy.
Conduct regulatory risk assessments and ensure integration of compliance requirements in product development.
Implement and manage regulatory tracking systems, compliance matrices, and dashboards to monitor deliverables and performance.
Provide training and guidance to cross‑functional teams on regulatory expectations, documentation practices (ALCOA+ principles), and compliance protocols.
Coordinate document translations and localization for international submissions and multi‑country product launches.
Maintain a repository of regulatory FAQs, templates, and guidance documents to support daily operations.
Report key compliance metrics and strategic risks to senior leadership, recommending mitigation plans.
Perform other duties as assigned to support regulatory and business objectives.
Knowledge, Skills, and Abilities
Strong knowledge of FDA, Health Canada, and international food regulations.
Expertise in GMP, LACF (Low Acid Canned Foods), and labeling standards.
Proficiency in document control systems, compliance tools, and regulatory tracking platforms.
Excellent communication, negotiation, and cross‑functional collaboration skills.
Experience working with legal counsel on regulatory matters.
Strategic thinking, proactive problem‑solving, and adaptability in a dynamic environment.
Ability to lead initiatives and influence outcomes without direct supervisory authority.
Qualifications
Bachelor’s degree in Law, Pharmaceutical Sciences, Chemical‑Biological Sciences, or related fields.
Valid professional license and degree certificate required.
Minimum 7 years in food industry regulatory roles.
Proven experience with FDA, CFIA regulations, and regulatory agency interactions.
Experience with LACF regulations and product registrations in the U.S. and Canada.
Other Requirements
Must be authorized to work in the U.S.
Availability to travel quarterly.
Ability to work flexible hours as needed to support operations.
Spanish advanced
Physical Requirements
Standard office environment.
Ability to attend on‑site audits and inspections.
Occasional travel to regulatory meetings or manufacturing sites.
Cab Enterprises Inc. is committed to maintaining a work environment that promotes diversity and is free of discrimination. Except where prohibited by state law, all offers of employment might be subject of passing a drug test.
#J-18808-Ljbffr