Job Description

The Senior Regulatory Affairs Specialist plays a critical role ensuring in-market regulatory compliance of new and existing products, packaging and communications. An experienced regulatory or technical professional, the Senior Specialist will have, or quickly develop, a strong understanding of applicable regulations, guidance and industry best practice pertaining to the product portfolio they support.

The individual will work independently with a high level of responsibility. In addition to label content management and formula review they will take ownership of and deliver successfully smaller projects and specific regulatory elements within larger projects.  

Review, maintain and create manuscript (label content) records for The Bountiful Company's product portfolio of Dietary Supplements, Foods, OTCs and Cosmetics, as applicable, by interpreting and applying applicable regulations and guidance.Compiles and interprets substantiation documentation for accurate and compliant labeling.As directed, take ownership of and deliver successfully smaller projects and specific regulatory elements within larger projects such as innovation, implementation of new regulations, portfolio assessment and change control.Support review of product ideations, raw material assessment, formulation assessment, new claims, labels, advertising materials, third party products and related brand activitiesCompile dossiers to support license or registration submissions or updates ensuring compliance with regulatory requirements, as applicableUS region: Draft FDA 30 Day Notification LettersPerforms various calculations and evaluations to substantiate compliant labeling: formula, percent daily values, vitamin & mineral conversions, nutritional claim support, structure/function claims.Develop and maintain accurate and compliant label content for portfolio dietary supplements, foods, over the counter drug and cosmetic products, as applicable.Demonstrates high level of understanding of applicable regulations and implements.Follows Safety, Health, and Environmental policies and procedures.Supervises and/or trains one or more regulatory associates, as relevant and when requiredPerforms other duties as assigned.

QualificationsIdeal candidate would have previous exposure to and application of regulations pertaining to dietary supplements, foods, cosmetics or OTC pharmaceutical categories, label development or a scientific/ technical backgroundFunctional experience: 3 to 5 years of relevant prior business experience preferred. 1 to 2 years of experience in a regulatory affairs, quality or equivalent technical role preferred.Education: Bachelor degree required.

Skills

Strong written and verbal communication skillsA self-starter with willingness to learn and developDemonstrates strong team work, collaboration, attention to detail, analytical skills, and organizationBasic computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint