Regulatory Claims Substantiation Specialist

5 hours, 58 minutes ago
Full-time
Mid Level
Technical Writing and Documentation
Nordic Naturals

Nordic Naturals

Nordic Naturals specializes in providing high-quality omega-3 supplements, which are essential nutrients recognized for their role in promoting optimal health.

Food Products
251-1K
Founded 1995

Description

  • Review scientific evidence on the biological effects of dietary supplement ingredients.
  • Review, summarize, and substantiate mechanistic and clinical evidence supporting product claims.
  • Propose revisions to claims substantiation documents and identify high-risk claims or language under DSHEA and FDA/FTC guidelines.
  • Partner with Regulatory, Research, Product Development, Marketing, and Education teams to support compliant claims and content.
  • Assess formula-related regulatory risks with the Product Development team and recommend improvements.
  • Perform substantive edits to technical documents, including grammar, terminology, organization, and content.
  • Manage multiple projects, establish priorities, and meet changing deadlines and project schedules.
  • Support regulatory review of marketing, product, and educational materials.
  • Contribute to regulatory knowledge management and complete substantiation reviews across the product portfolio.

Requirements

  • Master’s or bachelor’s degree in biology, biochemistry, pharmacology, physiology, or another life science field.
  • At least 3 years of regulatory experience with claims substantiation for finished dietary supplement products.
  • Knowledge of the nutraceutical industry and dietary supplement ingredients, forms, uses, and activities.
  • Applied knowledge of DSHEA, the FD&C Act, and 21 CFR Parts 101 and 111.
  • Ability to read and interpret scientific and clinical research across observational studies, interventional studies, and meta-analyses.
  • Familiarity with statistics, clinical trial design, experimental design, hypothesis testing, and laboratory or clinical data interpretation.
  • Excellent scientific writing and ability to present technical information to technical and non-technical audiences.
  • Ability to work independently and cross-functionally, manage multiple priorities, and meet deadlines.
  • Proficiency with Microsoft Office, Excel, Word, PowerPoint, Adobe Acrobat, and Google Workspace; EndNote familiarity preferred.
  • Strong written and spoken English, communication skills, attention to detail, integrity, and receptiveness to constructive feedback.

Benefits

  • Salary range of $103,000–$120,000.
  • Remote work for employees located more than 40 miles from the Watsonville, California headquarters.
  • Occasional onsite work for employees within 40 miles of headquarters.
  • Reasonable accommodations available for qualified individuals with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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