Key Responsibilities and Required Skills for Food Regulatory Specialist

🎯 Role Definition

As our Food Regulatory Specialist, you will be the in-house expert and guardian of our brand's compliance. You'll work cross-functionally with R&D, Marketing, and Quality Assurance to ensure every ingredient, label, and claim is accurate, substantiated, and compliant with a myriad of global regulations. This role is critical for mitigating risk, enabling market access, and upholding our commitment to delivering safe, high-quality products to our consumers. Your expertise will directly influence our product innovation pipeline and international growth strategy.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Assurance Technician / Specialist
Food Scientist (R&D)
Regulatory Affairs Coordinator

Advancement To:

Senior Food Regulatory Specialist
Regulatory Affairs Manager
Director of Regulatory Compliance

Lateral Moves:

Quality Assurance Manager
Supplier Quality Specialist
Product Development Scientist

Core Responsibilities

Primary Functions

Develop and approve legally compliant ingredient statements, nutrition facts panels, allergen declarations, and packaging claims for all new and revised products.
Ensure 100% compliance of all product formulas, labels, advertising, and promotional materials with U.S. FDA, USDA, and state regulations.
Act as the primary regulatory contact for R&D and Marketing, providing strategic guidance on the feasibility of new product concepts, ingredients, and claims from the initial ideation stage.
Review and approve final product artwork, marketing copy, website content, and digital media to ensure regulatory compliance and complete substantiation of all claims.
Monitor, interpret, and communicate emerging regulations and guidance from agencies like the FDA (FSMA), USDA, and international bodies (CFIA, EFSA), assessing their impact on the business.
Manage the entire lifecycle of product certifications (e.g., Organic, Non-GMO Project Verified, Kosher, Halal), including initial applications, documentation, and coordination of audits.
Maintain a robust and organized database of raw material specifications, supplier compliance documentation, and finished product information to ensure data integrity and traceability.
Coordinate with international consultants and internal teams to ensure full compliance with export and import requirements for key global markets.
Serve as the regulatory subject matter expert during internal and external audits, including FDA inspections, organic certification audits, and customer compliance reviews.
Lead the regulatory submission process for new products, including brand registrations, notifications, and obtaining necessary operational permits.
Conduct comprehensive regulatory risk assessments for new ingredients, novel technologies, and marketing campaigns to inform strategic business decisions.
Utilize nutritional software (e.g., Genesis R&D) to generate accurate Nutrition Facts Panels and perform detailed formula analysis for compliance and product development.
Respond to complex regulatory inquiries from government agencies, key accounts, and consumers in a timely, accurate, and professional manner.
Develop, implement, and maintain internal regulatory policies, standard operating procedures (SOPs), and best practices to ensure ongoing organizational compliance.

Secondary Functions

Provide regulatory support and documentation during crisis management events such as product recalls or market withdrawals.
Train cross-functional team members on key regulatory principles and updates to foster a company-wide culture of compliance.
Collaborate with the legal department to address complex regulatory challenges and interpret ambiguous legal requirements.
Manage the company's participation in digital transparency initiatives like SmartLabel™, ensuring all data is accurate and up-to-date.
Support the supplier approval process by reviewing and assessing the regulatory compliance documentation of potential new vendors.
Participate in industry trade associations and regulatory committees to stay at the forefront of policy changes and industry trends.
Assist the consumer affairs team in drafting technically accurate responses to inquiries related to ingredients, allergens, and nutritional information.

Required Skills & Competencies

Hard Skills (Technical)

Expertise in FDA & USDA Regulations: Deep, practical knowledge of U.S. food regulations, including 21 CFR, FSMA, NLEA, and FALCPA.
Food Labeling Proficiency: Demonstrated ability to create and validate compliant nutrition facts, ingredient lists, and allergen statements.
Nutritional Database Software: Hands-on experience with Genesis R&D, ESHA Food Processor, or similar nutritional analysis software.
International Food Law: Familiarity with international regulations, particularly in Canada (CFIA) and the EU (EFSA), for export purposes.
Specification Management: Experience using and managing product lifecycle management (PLM) or specification management systems.
Claims Substantiation: Proven ability to research, build, and maintain comprehensive substantiation dossiers for a variety of product claims.
Certification Management: Experience managing the process for obtaining and maintaining certifications like USDA Organic, Non-GMO Project Verified, Kosher, and/or Halal.

Soft Skills

Meticulous Attention to Detail: An exceptional ability to identify minute discrepancies in data, copy, and artwork.
Analytical Problem-Solving: The skill to dissect complex regulations, assess business impact, and formulate clear, actionable solutions.
Cross-Functional Collaboration: A natural ability to build relationships and work effectively with teams from R&D, Marketing, Legal, and Operations.
Project Management: Strong organizational skills to manage multiple projects with competing deadlines in a fast-paced environment.
Effective Communication: The ability to translate complex regulatory jargon into clear, concise, and practical guidance for a non-technical audience, both verbally and in writing.

Education & Experience

Educational Background

Minimum Education:

Bachelor of Science degree.

Preferred Education:

Master of Science degree or a professional certification such as Regulatory Affairs Certification (RAC).

Relevant Fields of Study:

Food Science
Nutrition or Dietetics
Biology / Chemistry
Regulatory Science

Experience Requirements

Typical Experience Range:

3-7 years of direct experience in a food regulatory affairs role within the CPG, food manufacturing, or ingredient supply industry.

Preferred:

Experience working with a diverse portfolio of food and beverage categories is highly desirable.
Proven experience launching new products and supporting international market expansion is a significant plus.