Assistant Regulatory Manager

CiboVita • Totowa, NJ • 1h ago

About Us:

At Cibo Vita, innovation drives everything we do. Based in Totowa, NJ, we craft premium healthy snacks under the Nature's Garden brand, combining quality ingredients with creative flavor and function. Our products are designed to support wellness, sustainability, and better snacking choices-helping consumers "Snack With Purpose."

Job Summary:

The Assistant Regulatory Manager leads Regulatory function, ensuring that all food products comply with the regulatory requirements of every market in which they are sold. The role combines hands-on technical ownership of global labeling and claim compliance including Nutrition Facts Panel, ingredient statements, claims, and substantiation, with day-to-day oversight of regulatory workflows and team members.

The position also owns the annual regulatory validation program, ensuring all scheduled validation activities are completed on time and audit ready. In addition, the Assistant Regulatory Manager manages the regulatory project portfolio, serves as the primary liaison with external regulatory consultants and law firms, and owns the integrity of regulatory data held in SpecRight, TraceGains, or Cibo LIMS systems. The role acts as a delegate for the Sr Research and Development Manager when needed and partners closely with QA, Research and Development, Marketing, Packaging, and Sales to enable compliant, on-time product launches.

Key Responsibilities:

1.Team Support and Functional Oversight

Provide day-to-day directions, training, and mentorship to Regulatory Specialists.

Assign and balance workload across the team; monitor progress against committed timelines.

Perform secondary or final review of labels, claims, and regulatory documentation.

Develop, document, and maintain regulatory SOPs, review checklists, and internal work instructions.

Support hiring, onboarding, goal setting, and performance feedback in partnership with the Research and Development Manager.

Represent Regulatory Affairs in leadership and cross-functional meetings.

Global Label & Claim Compliance

Prepare, review and approve product labels and claims against the requirements of every market in which the product is sold.

Maintain current working familiarity with market-specific labeling and claim regulations, including United States, Canada, Mexico, UK / EU, China, and Korea.

Ensure claim substantiation is valid and defensible, not merely present - including verification that:

Supporting studies, analytical data, and test reports match the marketed formulation and serving size

Analytical methods are fit for purpose and performed by qualified laboratories

Documentation is current, within any applicable validity period, and meets the evidentiary standard of each market

Substantiation is retained, indexed, and retrievable for audit or enforcement inquiry

Serve as the escalation point for complex, novel, or high-risk labeling and claim questions across markets.

Provide clear regulatory guidance, risk assessments, and documented decisions to internal stakeholders.

Annual Validation Program Ownership

Own the annual regulatory validation program and ensure all scheduled elements are completed on time, fully documented, and audit-ready including below:

Nutrition Facts Panel (NFP) validation against current formulation and analytical data

Claim validation and re-substantiation for all active product claims

Specification and artwork review for accuracy, currency, and alignment to the approved formula

Key raw material validation, including supplier specifications, certificates, and regulatory status

Characteristics report validation

Maintain the annual validation calendar, assign owners, and track each item through to completion.

Monitor progress against the schedule, escalate at-risk items early, and drive mitigation plans to closure.

Trigger corrective action where validation results fall outside declared values or tolerances, including retesting, label revision, or specification update.

Maintain complete evidence of completion and approval to support customer audits and regulatory inspections.

Report program status and findings to the R&D manager and cross-functional leadership.

Regulatory Project & Consultant Management

Own the regulatory project portfolio, including prioritization, resourcing, and milestone tracking.

Act as the primary point of contact for external consultants, law firms, and regulatory service providers.

Document requests and consolidation of consultant feedback.

Invoice review and tracking against approved budget.

Translate external regulatory guidance into clear, actionable internal direction.

Verify that consultant deliverables meet applicable market requirements and internal standards before acceptance.

Food Regulatory Expertise

Apply FDA and comparable international regulations across conventional foods including:

Ingredient compliance (GRAS)

Category-specific labeling and claim requirements

21 CFR

Guide regulatory decision-making during new product development, reformulation, and line extensions.

Monitor FDA, FTC, state-level, and key international regulatory developments and communicate business impact proactively.

Assess regulatory risk for novel ingredients, new categories, and emerging claim strategies.

Specification, System & Documentation Governance

Oversee the accuracy, completeness, and consistency of regulatory data in SpecRight, TraceGains, or Cibo LIMS system.

Establish and enforce data standards for:

Ingredient and formulation data

Allergen information

Regulatory attributes, certifications, and supporting documentation

Ensure version control, audit readiness, and traceability of all regulatory records.

Lead responses to customer regulatory questionnaires and documentation requests.

Support internal audits, customer audits, and regulatory inspections with accurate documentation.

Artwork Review & Cross-Functional Collaboration

Provide final regulatory approval of packaging artwork prior to print or release.

Partner with Marketing, R&D, QA, Packaging, and Supply Chain to implement compliant label language.

Participate in stage-gate and launch readiness meetings to keep regulatory deliverables on schedule.

Coach commercial teams on claim boundaries and regulatory expectations to reduce late-stage rework.

New Market Entry & Export Support

Lead regulatory assessment of new markets under consideration, including feasibility, labeling, and registration requirements.

Identify labeling gaps, translation needs, and documentation requirements for export products prior to shipment.

Coordinate in-country consultants or distributor regulatory contacts to support market entry.

-

Qualifications:

Master's or PHD degree in Food Science, Nutrition, Regulatory Affairs, or a related field.

Requirements:

Experience

5+ years of regulatory experience in the food and dietary supplement industry.

2-3 years of experience leading, mentoring, or formally supervising regulatory staff.

Demonstrated experience reviewing:

FDA Nutrition Facts Panels

Ingredient statements and allergen declarations

Claims and claim substantiation documentation

Proven project management experience, including managing external regulatory consultants or law firms.

Hands-on experience using SpecRight, TraceGains, or comparable specification / regulatory management systems.

Knowledge & Skills

Strong working knowledge of FDA food and dietary supplement regulations.

Experience managing regulatory documentation within digital systems.

Ability to synthesize complex regulatory feedback into actionable guidance.

Strong organizational and time-management skills to manage multiple projects simultaneously.

Core Competencies

High attention to detail and sound regulatory judgment

Independent, proactive working style

Clear written and verbal communication

Collaborative, solutions-oriented mindset

What do we offer:

Medical, Dental and Vision Benefits

Life Insurance

401K

PTO

Company Paid Holidays

Career advancement and training

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