Regulatory Claims Substantiation Specialist

Nordic Naturals

. Review in-depth scientific evidence of the biological effects of ingredients used in Nordic Naturals products .

Posted 10/9/2026full-timeWatsonville • California • United StatesMid-LevelSenior💰 $103,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and claims substantiation within the dietary supplement industry, with a strong foundation in biochemistry, pharmacology, and scientific writing. Capable of managing multiple projects while ensuring adherence to DSHEA and FDA/FTC guidelines.

Highest-signal resume keywords

Regulatory ComplianceClaims SubstantiationScientific WritingNutraceutical Industry KnowledgeProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiochemistryPharmacologyClinical ResearchStatistical AnalysisExperimental DesignClaims ReviewMechanistic Evidence AnalysisPharmacokineticsPhysiological EffectsNutritional Science

Soft Skills

CollaborationAttention to DetailCommunicationProblem SolvingTime Management

Tools & Technologies

Microsoft Office SuiteGoogle SuiteEndNoteMacintosh OS X

Industry Keywords

DSHEAFD&C ActDietary SupplementsNutraceuticalsClinical OutcomesHealth ClaimsRegulatory RiskClaims DocumentationScientific EvidenceCross-Functional Collaboration

About the role

Key responsibilities & impact

Review in-depth scientific evidence of the biological effects of ingredients used in Nordic Naturals products
Partner with research and regulatory functions to ensure regulatory compliance
Propose revisions to claims substantiation documents supporting health claims under DSHEA and FDA/FTC guidelines
Identify and propose revisions to high-risk claims and language in internal claims documents
Develop expertise in terminology, biochemistry, molecular biology, physiology, pharmacology, and clinical outcomes associated with dietary ingredients and structure-function claims
Review, summarize, and substantiate mechanistic and clinical evidence supporting product claims
Understand and articulate molecular mechanisms, biochemical functions, pharmacokinetics, physiological effects, and pharmacological and clinical evidence from observational, interventional, and meta-analysis studies
Communicate and collaborate with team members to plan, develop, and produce high-quality communication products
Manage projects according to schedules and deadlines
Work simultaneously on multiple projects while setting priorities as deadlines and scope change
Perform substantive edits, correcting grammar, technical usage, content, and organizational problems
Adjust processes to accommodate changes and resolve issues
Collaborate with Product Development to assess regulatory risk of formulas and improve formulas as needed
Support Regulatory with review of marketing, product, and education content
In the first year, learn Nordic Naturals' regulatory risk tolerance and cross-functional substantiation standards
Complete product claims substantiation review for the Nordic Naturals product portfolio
Contribute to regulatory content knowledge-management improvements

Requirements

What you’ll need

D., Master of Science, or a Bachelor of Science degree in biology, biochemistry, pharmacology, physiology, or other life sciences
At least three years of regulatory experience related to claims substantiation for finished products in the dietary supplement industry
Knowledge pertaining to the nutraceutical industry and familiarity with ingredients, their usage, forms, activities, and relevant characteristics
Knowledge and applied experience of food or supplement regulations, including DSHEA, FD&C Act Section 21 CFR 101 and 111
Experience reading and understanding scientific and/or clinical research studies
Familiarity with statistics, clinical trial design, experimental design, hypothesis testing, and interpretation of laboratory and clinical research data
Ability to read and interpret standard operating procedures and regulations
Excellent fluency in spoken and written English
Skilled in scientific writing, comprehension, and presentation of technical information to technical and non-technical audiences
Ability to work cross-functionally with many departments and skill levels
Macintosh OS X environment proficiency
Microsoft Office suite, including Excel, Word, PowerPoint, and Adobe Acrobat
Google Suite proficiency
Familiarity with EndNote preferred
Ability to work independently and collaboratively, meet deadlines, prioritize multiple simultaneous tasks, and maintain attention to detail