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Witt/Kieffer

Regulatory Affairs Manager

Witt/Kieffer, Houston, Texas, United States, 77246

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EOE Statement: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Category: Administration Overview

CAB Enterprises, Inc. proudly serves as the exclusive distributor of Electrolit in the United States. Electrolit is owned by Grupo Pisa, Latin America's premier pharmaceutical company with over 80 years of experience. Electrolit has become a leader in premium hydration beverages. Since Electrolit entered the US in 2015, we have increased Electrolit's visibility in the U.S. market, by building on the brand’s rich legacy that began in 1950 as a hydration solution for children. With a steadfast commitment to quality, Electrolit has an innovative, scientifically backed formula, an exciting range of flavors, which uses pharmaceutical-grade ingredients and produced in a state-of-the-art facility. At CAB Enterprises, we pride ourselves on fostering a service-oriented culture that values the collective skills and contributions of our team members. Our core values: humility, honesty, respect, responsibility, and drive are the cornerstones of our success. We have a dynamic and fulfilling workplace where our employees are recognized as our most valuable asset. Together, we celebrate our achievements and look forward to continuing our tradition of excellence. 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 Principal Duties

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 (e.g. FDA, EU FIC). 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. Master’s degree preferred. 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.

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