Regulatory Claims Substantiation Scientist

Location: Remote / Watsonville, CA

Salary - 103K - 120K

Regulatory Claims Substantiation Scientist

• Job Summary:
• The Regulatory Claims Substantiation Scientist (RCSS) will review and propose revisions to claim substantiations in
• the form of compiled literature research and scientific writing from the research department. The RCSS will work
• both independently and collaboratively with members of the Regulatory, Research, Product Development (PD),
• Marketing, and Education teams. 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 researching topics and preparing, reviewing, 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 requirements.
• ● Propose revisions to claims substantiations documents to better support a specific health claim within

• DSHEA and FDA/FTC guidelines.
• ● Stay abreast of the latest dietary supplement risks from FDA, FTC, and third-party litigation.
• ● Identify and propose revisions to high-risk claims and/or language within internal claims documents.
• ● Drive continual self-education primarily through independent study of peer-reviewed scientific literature
• and recent court decisions impacting the dietary supplement industry.
• ● Develop expertise in the terminology, biochemistry, molecular biology, physiology, pharmacology and
• clinical outcomes associated with individual dietary ingredients and associated structure function claims.
• ● Attendance at scientific, regulatory, and legal conferences and seminars as necessary.
• ● 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.
• ● Maintain working knowledge of new and innovative products and industry trends.

• 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:
• ● Ph.D. or master’s degree in biology, biochemistry, or other life science; or an undergraduate degree in a
• life science with at least three years of regulatory experience related to claims substantiation in the
• dietary supplement industry.
• ● Must possess knowledge pertaining to the nutraceutical industry and must be well versed in a variety of
• ingredients, their usage, forms, activities and all other relevant characteristics.
• ● Knowledge and applied experience of food or supplement regulations (including DSHEA, FD&C Act Section
• 21 CFR 101 and 111) is required.
• ● Experience with reading and understanding all sections of scientific and/or clinical research studies.
• ● Must be receptive to constructive criticism and accept disagreement in a professional manner.
• ● Familiarity with statistics, clinical trials design, experimental design / hypothesis testing, and
• interpretation of laboratory and clinical research data.
• ● Must be able to read and interpret documents such as standard operating procedures, and regulations.
• ● Must be honest and demonstrate integrity. Scientific integrity and care for the well-being and trust of our
• customers is paramount.
• ● Ability to work independently and as part of a team, meet deadlines, be detail-oriented, perform and
• prioritize multiple simultaneous tasks. Organizational, and interpersonal skills are key.
• ● Excellent fluency in spoken and written English.
• ● Skilled in scientific writing, comprehension, and presentation of technical information to technical and
• non-technical audiences.
• ● Must be able to work cross functionally with many different departments and various skill levels.

• Competency Statements
• ● Positive - Ability to view all situations with a positive attitude.
• ● Accountable – takes ownership for responsibilities, acknowledges and learns from mistakes
• ● Innovative - Ability to look beyond the standard solutions and "think outside the box".
• ● Independent – Must be self-motivated and able to manage obligations without direct supervision
• ● Assertiveness - Ability to act in a self-confident manner to facilitate completion of a work assignment or to
• defend a position or idea.
• ● Communication - Ability to communicate effectively with others using spoken and written word clearly
• and concisely.
• ● Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
• ● Enthusiastic - Ability to bring energy to the performance of a task.
• ● Self-Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or
• her own drive or initiative.

Computer Skills:

•  Macintosh OS X environment
•  Microsoft Office suite including Excel, Word, and PPT, adobe Acrobat
•  Google suite
•  Prefer familiarity with EndNote