Location:- Pleasanton, CA (This is a Remote Position)
Title:- Ingredient and Product Safety Specialist (Regulatory Consultant)
Contract:- Till December 2019
This is a remote position.
Review and evaluate the results of preclinical toxicological studies submitted in support of Dietary ingredients and Dietary Supplement legacy finished products. Evaluate ingredients, and their effects on humans. Provide consultation on toxicology issues. The position is a regulatory role focused on supporting the compliance and safety of legacy products for our recently acquired Nutranext dietary supplement business.
Key Responsibilities (in descending order of importance) and % of Time:
Conduct and/or coordinate reviews and toxicological evaluations of legacy finished products and ingredients, including testing plans and data generated to support product safety.
Develop technical documents on various scientific, risk assessment, and regulatory topics, including toxicological data summaries for legacy products
Lead and/or assist with the preparation of documents in support of regulatory submissions
Years and Type of Experiences:
o MS/Ph.D. in Food Toxicology, Toxicology, or related discipline with 5+ years of industry or regulatory experience in the dietary supplement industry. Will consider other relevant experience in consumer goods industry, such as food and beverage.
o Excellent written/oral and communication skills.
o 6-8 years experiences (preferably in industry) in the FDA dietary supplement Regulatory space.
o In-depth working knowledge of FDA dietary supplement product regulations, guidance and policies for label claims, ingredients, formulations and processes.
o A thorough understanding of the FDA enforcement landscape (e.g. including trends/hotspots and state versus federal enforcement).
o Experience in regulation of dietary supplements (equivalent) outside of the U.S. (e.g., Canada Natural Health Products, European Food Supplements, etc.).
o MS/Ph.D. in Food Toxicology, Toxicology, or related discipline – preferred.
o Bachelor’s degree with experience