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Regulatory Manager at Harvest Hill

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Stamford, Connecticut





Job Description:

Regulatory Manager

Company Description

Formed in June 2014, Harvest Hill has grown into one of the nation's leading independent beverage companies in the U.S. Our family of iconic brands, including Juicy Juice®, SunnyD®, Veryfine®, Fruit2O®, Little HUG®, Daily's Cocktails®, Nutrament® and Green Beginnings® will continue to delight families for years to come. Harvest Hill Beverage Company is located in Stamford, CT and is owned by private equity firm Brynwood Partners. For more information, visit harvesthill.com.

Overview

The Harvest Hill Beverage Co. Regulatory Manager is responsible for ensuring regulatory systems are comprehensively and accurately managed, programs meet HHBC, FDA, state and local regulations. The candidate shall be well-versed in labeling compliance management, proven experience and understanding of FDA 21CFR Code. The position to reside in Stamford CT and reports to the Sr. Director of QA, Food Safety and Regulatory. The Regulatory Manager successfully provides regulatory guidance, develops management system platforms for Harvest Hill Beverage Co. Up to 10% travel may be required.

Responsibilities


  • Lead regulatory compliance for HHBC Brands through proactive collaboration

  • Standardize labeling practices and centralize regulations Interpret federal and state regulations and provide guidance to cross-functional teams (e.g., FDA, California Prop65, container deposit) and monitor and communicate changes to (e.g., new GMO law, new Nutrition Facts Label)

  • Review and provide regulatory guidance on:

    • Company's website

    • Product claims and claims substantiations

    • Finished product legal label copy

    • Package graphics (including Nutritional Facts Panel - NFP)



  • Engage in Product Development program support through the review of finished product formula cards (recipes), nutrition information and ingredient statement

  • Direct support of the SARF program Supplier Approval Review program with regulatory review of supplier documents, raw materials and primary packaging

  • Support manufacturing sites with review and approval of exceptional releases with regards to regulatory risk

    • Perform calculations to assess compliance with product label

    • Track stability of nutrients in finished product (e.g., vitamin C) to confirm assumed shelf life claims are met

    • Build kinetic models for determining nutrient content in finished products and support product shelf-life:

    • to ensure compliance with claims made

    • to meet customer demands

    • to minimize risk of product failure and write-off

    • to improve efficiencies in terms of material management



  • Review and approve basic material components and verify accuracies

  • Ensure label compliance when under soft and/or hard conversion

  • Provide regulatory guidance and ensure compliance with relevant FTA agreements (e.g., research terms of agreement to assess if product qualifies for preferential tariffs, create USMCA certification, obtain certificates of free sale)

Qualifications:


  • Candidate should possess a BS degree in Food Nutrition, Regulatory Compliance, Food biology or related field.

  • Ability to follow and comply with CFR 21Code standards and instructions.

  • Exemplify proven regulatory compliance and nutritional labeling skills with a minimum of 5 years' experience in Food labeling regulations.

  • Excellent attention to detail with organizational and planning skills.

  • Ability to self-manage, prioritize and work under pressure to tight deadlines.

  • Ability to communicate laterally with colleagues, participants and external stakeholders.

  • Excellent communication skills in English, both written and oral, are required.

  • Effectively report regulatory risks and ensure direct supervisor is apprised of key issues.

  • Ability to work effectively as part of a team.

  • Travel up to 10% may be required.

  • Undertake any training and professional development as and when required.

  • Proficient in Genesis, Nutritional Calculations, Microsoft Office, particularly Access, Word and Excel.

  • Basic knowledge of nutritional assessment and ability to apply sampling techniques (Exposure to Lean / Six sigma tools and training).





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