Job Application for Regulatory Claims Substantiation Scientist at Nordic Naturals

New

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

First Name

Last Name

Preferred First Name

Country

Phone

Location (City)

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

LinkedIn Profile

Website

Will you be able to provide proof of your identity and employment eligibility if you are hired?

Select...

Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)?

Select...

I hereby authorize Nordic Naturals, to thoroughly investigate my references, work record, education and other matters related to my suitability for employment and, further, authorize the references I have listed to disclose to the company any and all letters, reports and other information related to my work records, without giving me prior notice of such disclosure. In addition, I hereby release the Company, my former employers and all other persons, corporations, partnerships and associations from any and all claims, demands or liabilities arising out of or in any way related to such investigation or disclosure.

Select...

I hereby certify that I have not knowingly withheld any information that might adversely affect my chances for employment and that the answers given by me are true and correct to the best of my knowledge. I further certify that I, the undersigned applicant, have personally completed this application. I understand that any omission or misstatement of material fact on this application or on any document used to secure employment shall be grounds for rejection of this application or for immediate discharge if I am employed, regardless of the time elapsed before discovery.

Select...

I understand that nothing contained in the application or conveyed during any interview which may be granted or during my employment, if hired, is intended to create an employment contract between me and the Company. In addition, I understand and agree that if I am employed, my employment is for no definite or determinable period and may be terminated at any time, with or without prior notice, at the option of either myself or the Company and that no promises or representations contrary to the foregoing are binding on the Company unless made in writing and signed by me and the Company’s designated representative.

Select...

Should a search of public records (including records documenting an arrest, indictment, conviction, civil judicial action, tax lien or outstanding judgment) be conducted by internal personnel employed by the Company. I am entitled to copies of any such public records obtained by the Company unless I indicate waiver below. If I am not hired as a result of such information, I am entitled to a copy of any such records even though I have waived below.

Select...

I waive receipt of a copy of any public record described in the paragraph above.

Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.

How would you describe your gender identity?

Select...

How would you describe your racial/ethnic background?

Select...

How would you describe your sexual orientation?

Select...

Do you identify as transgender?

Select...

Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning?

Select...

Are you a veteran or active member of the United States Armed Forces?

Select...

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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Regulatory Claims Substantiation Scientist

Apply for this job

U.S. Standard Demographic Questions

Voluntary Self-Identification

Voluntary Self-Identification of Disability