Remote Regulatory Claims Scientist — Substantiation & Writing

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

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.