Location: Remote / Watsonville, CA
Salary - 103K - 120K
About Nordic Naturals
At Nordic Naturals, we take pride in crafting foundational nutrients to help people all over the world live healthy lives. Our mission is to give people, pets, and families the highest-quality nutrients possible to be well and support optimal health. This seemingly simple mission of global health relies on a dedicated team of motivated employees who share our passion for nutrition and wellness. Join us and discover how rewarding it can be to make a living while contributing to a truly great cause.
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.
Essential Functions & Core Responsibilities
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).
Communicates and collaborates with team members to plan, develop, and produce high-quality communication products in a dynamic environment.
Manages projects in a timely fashion and adheres to project schedules and deadlines.
Works simultaneously on multiple projects, independently setting work priorities to meet changing deadlines and scope-of-work definitions.
Performs substantive edits, correcting grammar, technical usage, content, and organizational problems
Adjusts processes to accommodate changes and resolve issues.
Collaborate with the PD Team to assess regulatory risk of formulas and improve existing formulas as necessary.
Support the regulatory department with review of marketing, product, and education content.
Key Contributions in First Year
Achieve an understanding of current Nordic Naturals regulatory risk tolerance and cross functional alignment (marketing, legal, research, etc.) on substantiation standards.
Complete product claims substantiation review for the Nordic Naturals product portfolio.
Develop understanding of current product and regulatory data and contribute to the improvement of overall knowledge management practices for regulatory content.
Position Qualifications
There are 2 essential requirements:
D., Master of Science, or a Bachelor of Science degree in biology, biochemistry, pharmacology, physiology, or other life sciences AND
At least three years of regulatory experience related to claims substantiation for finished products in the dietary supplement industry .
Must possess knowledge pertaining to the nutraceutical industry and must be well versed in a variety of…