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.