Regulation Assistant Manager

Position Summary

Cibo Vita is seeking an experienced, detail-oriented Assistant Regulatory Manager to lead key regulatory affairs activities across our food product portfolio. This role combines hands-on technical expertise in food labeling, claims substantiation, and global regulatory compliance with team leadership, project management, and cross-functional collaboration.

Reporting to the Senior Research & Development Manager, the Assistant Regulatory Manager will oversee regulatory labeling and artwork approvals, annual validation programs, regulatory documentation, product specification data integrity, and external consultant relationships. This individual will provide independent regulatory guidance, proactively assess compliance risks, and partner with R&D, Quality Assurance, Marketing, Packaging, Supply Chain, and Sales to support successful product development and on-time launches.

The ideal candidate brings strong FDA food regulatory knowledge, practical experience with international labeling requirements, and the ability to balance regulatory rigor with business objectives.

Key Responsibilities

1. Regulatory Leadership and Team Development

• Provide daily direction, training, and mentorship to Regulatory Specialists.
• Assign and prioritize workloads, monitor progress, and ensure timely, accurate regulatory deliverables.
• Perform secondary and final reviews of labels, claims, specifications, and regulatory documentation.
• Develop and maintain regulatory SOPs, review checklists, and work instructions.
• Support hiring, onboarding, goal setting, and performance feedback in partnership with R&D leadership.
• Represent Regulatory Affairs in cross-functional meetings and serve as an escalation point for complex regulatory issues.
• Act as a delegate for the Senior R&D Manager when needed.

1. Global Food Labeling and Claims Compliance

• Review and approve product labels, Nutrition Facts Panels (NFPs), ingredient statements, allergen declarations, and marketing claims for applicable markets.
• Maintain working knowledge of food labeling and claims regulations in the United States, Canada, Mexico, the United Kingdom, the European Union, China, South Korea, and other relevant markets.
• Interpret applicable FDA regulations, including relevant provisions of 21 CFR, as well as FTC requirements and international food regulatory standards.
• Evaluate ingredient acceptability, GRAS status, food additive requirements, and applicable formulation and labeling restrictions.
• Verify that nutritional, functional, comparative, and other product claims are scientifically substantiated, appropriately worded, and compliant.
• Ensure claim substantiation aligns with the marketed formulation, serving size, analytical data, test methods, and applicable market requirements.
• Confirm supporting studies, laboratory reports, and documentation are current, scientifically appropriate, and audit-ready.
• Assess regulatory risks related to novel ingredients, reformulations, new product categories, and emerging claims.
• Monitor regulatory developments and communicate business impacts, compliance risks, and required actions to stakeholders.

1. Annual Regulatory Validation Program

• Own the annual regulatory validation program, ensuring all activities are completed on schedule, properly documented, and audit-ready.
• Maintain the validation calendar, assign responsibilities, track milestones, and report program status to R&D leadership.
• Coordinate validation of: o Nutrition Facts Panels against current formulations and applicable analytical data. o Product claims and supporting substantiation. o Product specifications and packaging artwork. o Key raw materials, supplier specifications, certificates, and regulatory status. o Product characteristics reports and related regulatory documentation.
• Identify overdue or at-risk activities, implement mitigation plans, and drive corrective actions to closure.
• Investigate discrepancies between declared values, analytical results, formulations, and approved specifications.
• Coordinate retesting, label revisions, or specification updates when necessary.
• Maintain documented approvals, findings, and corrective actions for audits and regulatory inspections.

1. Regulatory Project and Consultant Management

• Manage the regulatory project portfolio, including prioritization, timelines, resource coordination, and milestone tracking.
• Serve as the primary contact for external regulatory consultants, law firms, laboratories, and service providers.
• Translate external regulatory guidance into clear, actionable recommendations.
• Review consultant deliverables for technical accuracy, completeness, and compliance.
• Review invoices and monitor spending against approved budgets.
• Identify project risks and dependencies that could affect product launches, compliance, or market entry.

1. Product Development and Cross-Functional Support

• Partner with R&D, QA, Marketing, Packaging, Supply Chain, and Sales throughout the product development lifecycle.
• Provide early regulatory assessments for new products, reformulations, line extensions, and ingredient substitutions.
• Evaluate ingredient compliance, formulation restrictions, labeling implications, and claim feasibility.
• Participate in stage-gate and launch readiness meetings to ensure regulatory deliverables meet project timelines.
• Provide guidance on product positioning, nutritional messaging, and marketing claims.
• Recommend practical solutions that maintain compliance while supporting innovation and commercial objectives.
• Communicate regulatory requirements clearly to technical and nontechnical stakeholders.

1. Regulatory Systems and Documentation Governance

• Oversee the accuracy, completeness, and integrity of regulatory data in SpecRight, TraceGains, Cibo LIMS, or comparable systems.
• Maintain data standards for ingredient and formulation information, allergens, regulatory attributes, certifications, and supporting documentation.
• Ensure document control, version management, traceability, and appropriate approval records.
• Resolve discrepancies between approved formulations, product specifications, and packaging artwork.
• Lead or coordinate customer regulatory questionnaires and product documentation requests.
• Support internal audits, customer audits, and regulatory inspections with accurate, accessible records.
• Improve regulatory workflows, documentation standards, and system utilization.

1. Packaging Artwork and International Market Compliance

• Provide final regulatory review and approval of packaging artwork before printing or production release.
• Verify ingredient statements, allergen declarations, Nutrition Facts Panels, claims, required disclosures, and other label elements.
• Ensure artwork aligns with approved formulations, specifications, and substantiation records.
• Coordinate artwork revisions with Marketing, Packaging, R&D, QA, and external partners.
• Assess regulatory requirements for new international markets, including ingredient acceptability, labeling, translations, registrations, and export documentation.
• Coordinate with international consultants, distributors, and in-country representatives to support market entry and ongoing compliance.

Qualifications

Education

• Bachelor’s degree in Food Science, Food Technology, Nutrition, Regulatory Affairs, or a related scientific discipline required.
• Master’s degree or Ph.D. preferred. Experience
• Minimum of 5 years of regulatory affairs experience in the food, beverage, dietary supplement, or related consumer packaged goods industry.
• 2–3 years of experience leading, mentoring, or supervising regulatory staff or managing regulatory workstreams.
• Demonstrated hands-on experience reviewing FDA Nutrition Facts Panels, ingredient statements, allergen declarations, product claims, and packaging artwork.
• Proven experience evaluating and maintaining scientific substantiation for product claims.
• Experience interpreting FDA food regulations, including applicable 21 CFR requirements.
• Familiarity with international food labeling and claims requirements.
• Experience managing regulatory projects, external consultants, or legal advisors.
• Experience with regulatory documentation and product specification management systems.
• Experience with validation programs, product launches, audits, or regulatory inspections preferred. Technical Skills
• Strong knowledge of FDA food labeling, ingredient compliance, allergen declarations, Nutrition Facts Panel requirements, and applicable FTC requirements for claims.
• Familiarity with GRAS determinations, food ingredient requirements, and international regulatory standards.
• Ability to assess the quality, relevance, and defensibility of scientific and analytical claim substantiation.
• Experience with SpecRight, TraceGains, Cibo LIMS, or comparable regulatory and specification management platforms.
• Proficiency in Microsoft Office and regulatory documentation management. Core Competencies
• Strong regulatory judgment and risk assessment capabilities.
• Exceptional attention to detail and commitment to compliance.
• Leadership, mentorship, and workload management skills.
• Strong project management and organizational abilities.
• Clear written and verbal communication.
• Independent, proactive problem-solving and decision-making.
• Collaborative, solutions-oriented approach.
• Ability to manage competing priorities and meet deadlines.

What We Offer

• Medical, dental, and vision benefits.
• Life insurance.
• 401(k) retirement plan.
• Paid time off (PTO).
• Company-paid holidays.
• Career advancement opportunities.
• Professional development and training.