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Regulatory Claims Substantiation Specialist
Evaluate scientific research and support substantiation of dietary supplement claims at Nordic Naturals. Work with regulatory, research, product development, marketing, and education teams.
संयुक्त राज्य
कैलिफ़ोर्निया$1,03,000 – $1,20,000 / वर्ष
हाइब्रिडपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालनविवरण
- Assess scientific evidence on the biological effects of ingredients in Nordic Naturals products.
- Coordinate with research and regulatory teams to support compliance.
- Recommend updates to claim substantiation documents for health claims under DSHEA and FDA/FTC guidance.
- Flag high-risk claims and wording in internal documents and recommend revisions.
- Build subject-matter knowledge in life sciences and clinical outcomes relevant to dietary ingredients and structure-function claims.
- Evaluate and summarize mechanistic and clinical evidence that supports product claims.
- Explain molecular mechanisms, biochemical functions, pharmacokinetics, physiological effects, and evidence from observational, interventional, and meta-analysis studies.
- Work with colleagues to plan and produce clear, high-quality communications.
- Keep projects on schedule and meet deadlines.
- Manage concurrent projects and reprioritize as deadlines or scope change.
- Edit documents for grammar, technical accuracy, content, and organization.
- Adapt processes when circumstances change and resolve issues.
- Partner with Product Development to assess formula risks and recommend improvements where needed.
- Help Regulatory review marketing, product, and educational materials.
- Learn the company’s risk tolerance and cross-functional substantiation standards during the first year.
- Review and substantiate claims across the Nordic Naturals product portfolio.
- Help improve knowledge management for regulatory content.
आवश्यकताएँ
- D., master's, or bachelor's degree in biology, biochemistry, pharmacology, physiology, or another life science.
- At least three years of dietary supplement industry regulatory experience focused on finished-product claims substantiation.
- Knowledge of the nutraceutical industry and familiarity with ingredients, their uses, forms, activities, and relevant characteristics.
- Knowledge and practical experience with food or supplement regulations, including DSHEA and FD&C Act regulations 21 CFR 101 and 111.
- Experience reading and understanding scientific or clinical research.
- Familiarity with statistics, clinical and experimental trial design, hypothesis testing, and interpretation of laboratory and clinical research data.
- Ability to read and interpret standard operating procedures and regulations.
- Excellent spoken and written English.
- Strong scientific writing and comprehension skills, with the ability to present technical information to technical and non-technical audiences.
- Ability to collaborate across departments and with colleagues at varying skill levels.
- Proficiency in the Macintosh OS X environment.
- Proficiency with Microsoft Office, including Excel, Word, and PowerPoint, and Adobe Acrobat.
- Google Suite proficiency.
- Familiarity with EndNote is preferred.
- Ability to work independently and collaboratively, meet deadlines, prioritize concurrent tasks, and maintain attention to detail.
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