Regulatory Claims Substantiation Scientist
$103,000–$120,000 year
On-siteWatsonville, California, United States
Job Summary
Review in-depth scientific evidence of biological effects for dietary supplement ingredients and propose revisions to claims substantiation documents aligned with DSHEA and FDA/FTC guidelines. Collaborate with Regulatory, Research, Product Development, Marketing, and Education teams to ensure compliance and manage projects while adhering to deadlines. Stay abreast of dietary supplement risks from FDA, FTC, and litigation through independent study of peer-reviewed literature and recent court decisions. Perform substantive edits on technical documents, summarize mechanistic and clinical evidence, and adjust processes to resolve issues. Work independently and cross-functionally to maintain high-quality communication products and improve knowledge management practices for regulatory content.
Required Qualifications
- Ph.D. or master's degree in biology, biochemistry, or other life science
- undergraduate degree in a life science with at least three years of regulatory experience related to claims substantiation in the dietary supplement industry
- knowledge pertaining to the nutraceutical industry
- 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)
- Experience with reading and understanding all sections of scientific and/or clinical research studies
- 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
- Ability to work independently and as part of a team
- meet deadlines
- be detail-oriented
- perform and prioritize multiple simultaneous tasks
- Organizational skills
- interpersonal skills
- 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
- Ability to view all situations with a positive attitude
- takes ownership for responsibilities
- Ability to look beyond the standard solutions and think outside the box
- Must be self-motivated and able to manage obligations without direct supervision
- Ability to act in a self-confident manner to facilitate completion of a work assignment or to defend a position or idea
- Ability to communicate effectively with others using spoken and written word clearly and concisely
- Ability to take care of the customers' needs while following company procedures
- Ability to bring energy to the performance of a task
- Ability to be internally inspired to perform a task to the best of his or her ability using his or her own drive or initiative
- Macintosh OS X environment
- Microsoft Office suite including Excel, Word, and PPT
- adobe Acrobat
- Google suite
- familiarity with EndNote
Desired Qualifications
- familiarity with EndNote
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.