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Specialist, Regulatory at The Bountiful Company in RONKONKOMA, New York

Posted in Other 30+ days ago.





Job Description:



Job Description




Company Description

The Bountiful Company, a Nestle Health Science Company, is a pure play branded leader in global nutrition, living at the intersection of science and nature. As a manufacturer, marketer and seller of vitamins, minerals, herbal and other specialty supplements, and active nutrition products, we are focused on enhancing the health and wellness of people's lives. The Bountiful Company's portfolio of trusted brands includes Nature's Bounty, Solgar, Osteo Bi-Flex, Puritan's Pride, Sundown and Ester-C.

Inclusion and Diversity in the workplace matters at The Bountiful Company. This includes being focused on retaining and recruiting a diverse workforce and building a culture of inclusivity. Our goal is to create a place where people feel respected, valued and able to bring their authentic selves to work each day.

Did we mention that we also offer excellent benefits, competitive compensation and a progressive, healthy company culture? If you've ever spent your workdays watching the clock, you know how important a positive work environment is for a person's well-being. The Bountiful Company is committed to supporting wellness in all forms. And when it comes to wellness, nature is a pretty good place to start.



Job Description

The Regulatory Affairs Specialist plays a critical role in ensuring in-market regulatory compliance of new and existing products, packaging and communications. 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 a portfolio of vitamins, minerals, herbal and other specialty supplements, and active nutrition products. As a critical part of regulatory operations, the individual will be expected to quickly develop and apply a thorough knowledge of applicable regulations, guidance and industry best practice.

Additional responsibilities include:


  • Review, maintain and create manuscript (label content) records for the company's product portfolioby 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 and 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. Providing accurate data on task completion in line with Key Performance Indicators/Metric requirements

  • Supports other regulatory tasks, as required, to ensure in-market regulatory compliance of new and existing products, packaging and communications

  • Supports review of supplier raw material documentation and updates company databases

  • Liaise between the company andexternal suppliers to ensure supplier documentation is accurate and complete and substantiates technical claims (e.g. Non-GMO); Support technical inquiries from various internal departments. Establish and demonstrate a thorough knowledge and understanding of applicable regulations and implements





Job Requirements



  • Ideal candidate will have previous exposure to regulations pertaining to dietary supplements or a scientific/ technical background

  • Experience reviewing documents, implementing SOPs and procedures, or other technical and detailed writing experience

  • 1+ year of relevant business experience preferred

  • Bachelor's 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



Ref # POS000002717







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