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Specialist, Regulatory

Company: The Bountiful Company
Location: Holbrook
Posted on: November 14, 2021

Job Description:

Company Description

The Bountiful Company is a USA-based, leading global vertically integrated manufacturer, marketer and distributor of a broad line of high-quality, premium and value-priced nutritional supplements throughout the world. - Our ongoing mission to deliver the highest quality nutritional supplements and wellness products has resulted in an extensive portfolio of well-known and trusted brands, including Nature's Bounty -, Sundown Naturals -, Osteo Bi-Flex -, Solgar -, and many others. The Bountiful Company is committed to supporting wellness by creating products that consumers want and making them easily available anywhere they shop. -
Job Description

The Regulatory Affairs Specialist plays a critical role in ensuring in-market regulatory compliance of new and existing products, packaging and communications. Under direction the Specialist will, in addition to other regulatory compliance tasks, be primarily responsible for developing and maintaining accurate and compliant formula and label content for portfolio dietary supplements, foods, over the counter drug and cosmetic products, as applicable. The individual will be expected to quickly develop and apply a thorough knowledge of applicable regulations, guidance and industry best practice. -A high level of support and supervision will be provided ensuring individual and company success.Under direction, supported by feedback and training:

  • Review, maintain and create manuscript (label content) records for TBCo's product portfolio of Dietary Supplements, Foods, OTCs and Cosmetics, as applicable, by interpreting and applying applicable regulations and guidance
  • Review and assess raw material, formula and related substantiation documents ensuring development of accurate and compliant labeling.
  • Performs various calculations as delegated to substantiate compliant labeling: formula, percent daily values, vitamin & mineral conversions, and all claims including nutrition content and structure/ function claims
  • Compile dossiers to support license or registration submissions or updates ensuring compliance with regulatory requirements, as applicable
  • Actively track and report efforts providing visibility of pending, in process and complete tasks (e.g. label manuscript development, registration/license dossier compilation), enabling workload, timeline and resource planning
  • Supports other regulatory tasks, as required, to ensure in market regulatory compliance of new and existing products, packaging and communications
  • Establish and demonstrate a thorough knowledge and understanding of applicable regulations and implements.
  • Follows Safety, Health, and Environmental policies and procedures.
  • Performs other duties as assigned.Job Requirements:Qualifications

    • Ideal candidate would have previous exposure to regulations pertaining to dietary supplements, foods, cosmetics or OTC pharmaceutical categories or a scientific/ technical background
    • Functional experience: 1 to 2 years of relevant prior business experience preferred.
    • Education: Bachelor degree required.
    • Strong written and verbal communication skills
    • A self-starter with willingness to learn and develop
    • Demonstrates strong team work, collaboration, attention to detail, strong analytical skills, and organization
    • Basic computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint
      Additional Information

Keywords: The Bountiful Company, Westport , Specialist, Regulatory, Other , Holbrook, Connecticut

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