Regulatory Claims Substantiation Specialist

Location: Remote / Watsonville, CA

Salary - 103K - 120K

Position Summary:

Based on compiled literature research and scientific writing from the research department, the  Regulatory Claims Substantiation Specialist (RCSS) will review and propose revisions to claim substantiations. The RCSS will work both independently and collaboratively with members of the Regulatory, Research, Product Development (PD), Marketing, and Education teams, as needed. In this capacity, the RCSS will review and propose revisions to the scientific evidence and rationale required to support the nutrition and health-related claims associated with the ingredients of dietary supplement products.  This work involves reviewing research output, preparing, revising, and maintaining technical documents.

Location Statement:

This is a remote position for those who live outside of 40 miles from Nordic Naturals headquarters in Watsonville, CA. Our culture is very important to us and for team members who live inside of the 40-mile radius, we expect them to be onsite occasionally to help support our collaborative community.

Reasonable Accommodations Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. 

Essential Functions:

• Review of in-depth scientific evidence of the biological effects of ingredients used in Nordic Naturals products.
• Partner with research & regulatory functions to ensure compliance to appropriate regulatory
• Propose revisions to claims substantiations documents to better support a specific health claim within DSHEA and FDA/FTC guidelines.
• Identify and propose revisions to high-risk claims and/or language within internal claims documents.
• Develop expertise in the terminology, biochemistry, molecular biology, physiology, pharmacology and clinical outcomes associated with individual dietary ingredients and associated structure function claims.
• Review, summarize and/or substantiate the mechanistic and clinical evidence supporting product claims
• Ability to understand and articulate relevant information including molecular mechanisms, biochemical functions, pharmacokinetics, physiological effects, pharmacological and clinical evidence from a range of study types (e.g., observational, interventional, meta-analysis).