Regulatory Affairs Scientist

Job Summary

The Regulatory Affairs Scientist reviews dietary supplements, cosmetic, and beverage labels and formulas for compliance; creates and maintains ingredient specifications; and coordinates third-party certification programs, including organic, non-GMO, and Halal. The position manages assigned regulatory projects through completion and applies foundational chemistry and mathematical concepts when reviewing formulas, specifications, and product labeling.

Essential Functions

Third-Party Certifications

• Coordinate third-party certification programs including USDA Organic, Non-GMO Project Verified, and Halal, and support additional programs such as Kosher, gluten-free, and vegan as the portfolio requires.

• Prepare and submit certification applications, annual renewals, and product addition requests; assemble supporting documentation and respond to certifier questions and audit findings.

• Track certification status across the product portfolio and flag expirations, gaps, and at-risk items before they affect production or retail listings.
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Label and Formula Review

• Review dietary supplement, cosmetic, and beverage labels for regulatory compliance and internal accuracy, including required panels, ingredient declarations, allergen statements, net quantity statements, and product claims.

• Review formulations for ingredient eligibility, applicable restrictions, permitted use levels, labeling implications, and third-party certification requirements.

• Verify that marketing claims are consistent with the supporting substantiation on file and appropriately qualified.

• Coordinate label review and revision cycles and verify that approved changes are incorporated into the final label.
  

Ingredient and Product Specifications

• Create, review, and maintain ingredient and finished product specifications, ensuring identity, grade, source, and quality parameters are accurately captured and kept current.

• Evaluate incoming ingredient documentation — specifications, certificates of analysis, allergen and GMO statements, country of origin, and regulatory status — against internal requirements and applicable regulations.

• Request, track, and follow up on required documentation from suppliers, contract manufacturers, government agencies, and certifying bodies until files are complete.
  

Project Management and Collaboration

• Manage multiple concurrent projects against launch timelines, keeping stakeholders informed of status, risks, and dependencies.

• Identify documentation gaps and potential compliance issues independently, recommend appropriate next steps, and escalate issues when additional review or guidance is needed.

• Serve as a regulatory resource to Marketing, R&D, Quality, Supply Chain, and Customer Service.

• Monitor regulatory developments relevant to dietary supplements, cosmetics, and beverages and support implementation of required changes.

• Other duties as assigned.
  

Additional Responsibilities

• Support of and involvement in company, department, and/or safety policies, procedures, programs and activities.

• Maintenance of a clean and orderly work area.

Job Qualifications

Required

• Bachelor’s degree in chemistry, biochemistry, biology, food science, nutrition, or a closely related scientific discipline.

• Up to 3 years of relevant experience in regulatory affairs, quality assurance, product compliance, food science, or a related field.

• Working understanding of basic chemistry principles, including compound identity, concentration, purity, and the difference between an ingredient and its active constituents.

• Ability to perform and verify calculations involving unit conversions (mcg, mg, IU), percent composition, overage calculations, percent Daily Value, and label rounding rules.

• Ability to accurately review detailed technical documents and identify inconsistencies, omissions, and errors.

• Ability to independently prioritize and advance multiple projects with competing deadlines.

• Clear written and verbal communication, including the ability to present findings and recommendations to cross-functional partners and to correspond professionally with external suppliers and certifying bodies.

• Proficiency with Microsoft Word and Excel and the ability to learn company and industry-specific systems.

• Ability to read, interpret, and apply regulatory text, scientific literature, and technical documentation.
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Preferred

• Coursework, internship, or work experience in regulatory affairs, quality assurance, or a related compliance function.

• Familiarity with laws, regulations, or guidance applicable to dietary supplements, cosmetics, food labeling, advertising claims, or consumer product warnings, such as DSHEA, 21 CFR Part 101 (labeling), 21 CFR Part 111 (dietary supplement cGMP), MoCRA and cosmetic labeling requirements, FTC advertising substantiation standards, or California Proposition 65.

• Prior exposure to third-party certification programs such as USDA Organic, Non-GMO Project, Halal, or Kosher.

• Experience with specification management, PLM, ERP, or label management systems.
  

Physical Requirements

• While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to touch, handle, or feel; reach with hands and arms; and talk or hear.

• The employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force to move objects.

• Specific vision abilities required by this job include near acuity, far acuity, depth perception, accommodation, color vision, and field of vision.