Regulatory Claims Substantiation Specialist
N
Nordic NaturalsDietary supplements
This is a remote position for those who live outside of 40 miles from Nordic Naturals headquarters in Watsonville, CA.Full-TimeMiddle
Salary103,000 - 120,000 USD per year
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Job Details
- Languages
- Excellent fluency in spoken and written English.
- Experience
- At least three years of regulatory experience related to claims substantiation for finished products in the dietary supplement industry.
- Required Skills
- Microsoft Excel
Requirements
- Hold a doctoral, Master of Science, or Bachelor of Science degree in biology, biochemistry, pharmacology, physiology, or another life science.
- Have at least three years of regulatory experience in claims substantiation for finished products in the dietary supplement industry.
- Have knowledge of the nutraceutical industry and dietary ingredient uses, forms, activities, and characteristics.
- Have applied knowledge of food or supplement regulations, including DSHEA and FD&C Act Sections 21 CFR 101 and 111.
- Be experienced in reading and understanding scientific and/or clinical research studies.
- Be familiar with statistics, clinical trial design, experimental design, hypothesis testing, and interpretation of laboratory and clinical research data.
- Be able to read and interpret standard operating procedures and regulations.
- Have excellent fluency in spoken and written English.
- Be skilled in scientific writing and in presenting technical information to technical and non-technical audiences.
- Be able to work independently and collaboratively, prioritize multiple tasks, and meet deadlines.
- Use Macintosh OS X, Microsoft Office including Excel, Word, and PowerPoint, Adobe Acrobat, and Google Suite.
- EndNote familiarity is preferred.
Responsibilities
- Review in-depth scientific evidence on the biological effects of ingredients used in company products.
- Partner with research and regulatory teams to support compliance with applicable regulations.
- Propose revisions to claims substantiation documents supporting health claims under DSHEA and FDA/FTC guidelines.
- Identify high-risk claims or language in internal claims documents and propose revisions.
- Review, summarize, and substantiate mechanistic and clinical evidence supporting product claims.
- Interpret molecular mechanisms, biochemical functions, pharmacokinetics, physiological effects, and clinical evidence across study types.
- Edit technical documents for grammar, technical usage, content, and organization.
- Collaborate with Product Development to assess formula regulatory risk and improve existing formulas as needed.
- Review marketing, product, and education content for the regulatory department.
- Manage multiple projects, schedules, priorities, and deadlines.
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