Regulatory Claims Substantiation Specialist

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

Job summary

Nordic Naturals is seeking a Regulatory Claims Substantiation Specialist to review and revise claim substantiations for dietary supplement ingredients. This remote role involves collaborating with Regulatory, Research, Product Development, Marketing and Education teams to ensure regulatory compliance and scientifically sound product claims.

You will assess scientific evidence, draft substantiation documents, and manage multiple projects with tight schedules while maintaining high quality

Qualifications

• Bachelor’s or MS in biology, biochemistry, pharmacology, physiology or life sciences.
• At least three years of regulatory experience related to claims substantiation for finished products in the dietary supplement industry.
• Familiarity with DSHEA, FDA/FTC guidelines and related regulations.

Responsibilities

• Review deep scientific evidence of ingredients used in Nordic Naturals products.
• Collaborate with regulatory, research, PD, marketing and education teams.
• Propose revisions to claims substantiations to support health claims per DSHEA and FDA/FTC guidelines.
• Identify high-risk claims and language needing revision in internal documents.
• Develop expertise in terminology, biochemistry, physiology and clinical outcomes of ingredients.
• Summarize and substantiate mechanistic and clinical evidence for product claims.
• Communicate complex information clearly to technical and non-technical audiences.
• Manage multiple projects and meet deadlines.

Skills

Regulatory experience

Scientific writing

Communication

Project management

Team collaboration

English fluency

Education

Biology/Biochemistry/Pharmacology degree

Tools

Microsoft Office (Excel, Word, PPT)

Adobe Acrobat

Google Suite

EndNote

Job description

Regulatory Claims Substantiation Specialist

Remote - USA; Watsonville, CA

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).
• 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 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:

• Microsoft Office suite including Excel, Word, and PPT, adobe Acrobat
• Google suite
• Prefer familiarity with EndNote

U.S. Standard Demographic Questions

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Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Nordic Naturals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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