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Nordic Naturals
Nordic Naturals
201 – 500 Angajați
Alimente și băuturiAsistență medicalăIndustria prelucrătoare
Nordic Naturals este o companie de produse pentru sănătatea consumatorilor, specializată în uleiuri omega-3 din pește și alge, vitamine, minerale, probiotice și suplimente gumate pentru oameni și animale de companie. Fondată în 1995, compania dezvoltă și produce formule axate pe puritate, prospețime, potență și utilizarea dovezilor științifice. Produsele sale ajung la clienți prin comerț electronic, programe de abonament și distribuție cu amănuntul, precum și prin linii de produse dedicate profesioniștilor și medicinei veterinare.
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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.

USStatele Unite ale AmericiiCACalifornia
103.000 $ – 120.000 $ / an
HibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăConformitate

Descriere

  • 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.

Cerințe

  • 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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