Regulatory Claims Substantiation Scientist

Nordic Naturals; Watsonville (CA); Hybrid; USD 103,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Job summary

Nordic Naturals seeks a Regulatory Claims Substantiation Scientist to review and revise claim substantiations based on literature research and scientific writing. You will work with Regulatory, Research, PD, Marketing and Education teams to support ingredient health and nutrition claims.

The role requires strong written and spoken English, experience with DSHEA/FDA/FTC guidelines, and the ability to interpret diverse clinical studies.

Qualifications

• Regulatory experience related to claims substantiation in the dietary supplement industry.
• Excellent fluency in spoken and written English.
• Skilled in scientific writing, comprehension, and presentation of technical information to technical and non-technical audiences.
• Knowledge of DSHEA and FDA/FTC guidelines.
• Ability to read and interpret scientific/clinical research studies.
• Familiarity with statistics, clinical trials design, experimental design / hypothesis testing, and interpretation of laboratory and clinical research data.

Responsibilities

• Review in-depth scientific evidence of the biological effects of ingredients used in Nordic Naturals products.
• Partner with research regulatory functions to ensure compliance to regulatory requirements.
• Propose revisions to claims substantiation documents to better support a health claim within DSHEA and FDA/FTC guidelines.
• Stay abreast of latest dietary supplement risks from FDA, FTC, and third-party litigation.
• Identify high-risk claims and language within internal claims documents.
• Drive continual self-education through independent study of peer-reviewed literature and recent court decisions.
• Develop expertise in terminology and outcomes related to dietary ingredients and structure/function claims.
• Review, summarize and substantiate mechanistic and clinical evidence supporting product claims.
• Communicate and collaborate with team members to plan and produce high-quality communication products.
• Manage projects in a timely fashion and adhere to schedules and deadlines.
• Work on multiple projects, independently setting priorities to meet deadlines.
• Perform substantive edits for grammar, terminology, content, and organization.
• Collaborate with the PD Team to assess regulatory risk of formulas and improve formulas as necessary.
• Maintain knowledge of new products and industry trends.

Job description

Regulatory Claims Substantiation Scientist

watsonville, ca

Location: Remote / Watsonville, CA

Salary - 103K - 120K

Regulatory Claims SubstantiationScientist

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