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 activities
- Compile dossiers to support license or registration submissions or updates ensuring compliance with regulatory requirements, as applicable
- US region: Draft FDA 30 Day Notification Letters
- Performs 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 required
- Performs other duties as assigned.
- Ideal 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 background
- Functional 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 skills
- A self-starter with willingness to learn and develop
- Demonstrates strong team work, collaboration, attention to detail, analytical skills, and organization
- Basic computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint
