Regulatory Claims Substantiation Scientist
Core
Review and propose revisions to scientific evidence and rationale supporting nutrition and health-related claims for dietary supplement ingredients.
Role type
Regulatory Claims Substantiation Scientist
Builds
Technical documents substantiating health claims for dietary supplement products
Domain
Dietary supplements / Regulatory compliance / Life sciences
Required skills
Scientific writing, regulatory compliance (DSHEA, FDA/FTC), literature review, data interpretation, project management, cross-functional collaboration
Preferred skills
Knowledge of nutraceutical ingredients, familiarity with statistics and clinical trial design
Technologies
Microsoft Office, Adobe Acrobat, Google Suite, EndNote
Responsibilities
Review in-depth scientific evidence of biological effects of ingredients; Partner with regulatory functions to ensure compliance; Propose revisions to claims substantiation documents; Stay abreast of dietary supplement risks from FDA, FTC, and litigation; Develop expertise in biochemistry, molecular biology, and physiology; Attend scientific and regulatory conferences; Summarize mechanistic and clinical evidence supporting product claims.
Seniority
Mid-level, independent contributor