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A prominent organization is seeking a senior regulatory scientist to lead projects on GRAS self-determinations and dietary ingredient notifications. The role involves designing toxicological studies, authoring scientific publications, and providing mentorship. Strong expertise in FDA/FTC regulations and toxicology is essential for success in this position.
Key Responsibilities:
Serve as the senior regulatory and scientist on client projects involving GRAS self-determinations (Independent Conclusions of GRAS Status), GRAS Notifications, and New Dietary Ingredient Notifications, involving FDA and/or FTC.
Design, monitor, and interpret toxicology studies (acute, subchronic, developmental, genotoxicity, etc.).
Design and critically review toxicological safety assessments for food ingredients, dietary supplements, and cosmetics, within a regulatory framework.
Author or co-author scientific manuscripts for peer-reviewed publication in support of regulatory dossiers from a toxicological viewpoint.
Ability to provide strategic solutions on FDA and FTC regulatory matters.
Provide mentorship and technical leadership to colleagues.
Remain update on current with evolving global regulations and scientific trends primarily relevant to food ingredient safety and compliance, and safety assessment technologies.