Arbonne International, LLC

  • Regulatory Affairs Specialist I | Nutrition

    Job Locations US-CA-Irvine
    Posted Date 4 weeks ago(4 weeks ago)
    ID
    2018-3973
    # of Openings
    1
    Category
    Regulatory Compliance
  • Overview

    The position of Regulatory Specialist 1 in Nutrition reports to the Manager of Regulatory Affairs in Nutrition and will work closely with R&D/Quality and Marketing. This position will entail ensuring the compliance of nutritional products in varying countries.

     

    Duties will include performing formula assessments, claims review, substantiation and licensing activities. It will also include creation/overseeing of product label from creation, starting with the artwork creation form (ACF) to the PDF, and finally to the Proof. In addition to labelling, this position will review marketing material from catalogues to web material.

     

    The Regulatory Specialist 1 is knowledgeable in product licensing activities such as premarket approvals (Canada NPN, AUST, etc.) and notifications (US FDA, EU and Asia markets). You will gain experience and contribute to the team by assisting senior officers through providing input and analyzing recorded data.

     

    Responsibilities

    • Perform ingredient reviews to ensure product compliance using the Health Canada NHPD database, TGA database and be familiar with EU Directives for Foods and Food Supplements, and other country databases as appropriate.
    • Assist with claims substantiation through Pubmed and other bona fide sources in support of Arbonne’s nutritional product portfolio
    • Develop/coordinate labels for the US, CA, UK, PL, GE, Austria, FR, IR, SP, IT, NL, AU and other countries:
      • Connect with Planning to determine label lead time & due date for next Production Order (PO) of finished goods.
      • Connect with internal Project Manager to establish label timeline.
      • Responsible for assigning the appropriate Regulatory Specialist to begin label change (accessing CRD for artwork pdf) by sending the label to Regulatory Specialist for review
      • Responsible for Initial Review of CCF & label change is conducted by the Regulatory Specialist - Label Coordinator to verify all changes from CCF/ACF have been implemented.
      • Responsible for closing out project in BaseCamp once projects are approved
      • Responsible for sending out Supplier Artwork Review Request as a low-resolution pdf file to TP for review and approval using the Artwork Approval Form (AAF) for final signatures.
      • Responsible for releasing to Senior Project Manager, Marketing Creative Services to send for proofs. The Regulatory Specialist - Label Coordinator shall be cc’d on all email communication with supplier to troubleshoot any issues
      • Ensure that an approved label change (CCF/ACF) is released from Document Control to the Regulatory Specialist - Label Coordinator.
      • Responsible to ensure that the project is opened in BaseCamp for Creative to edit.
      • Responsible to ensure that the project is returned to Regulatory Specialist - Label Coordinator from Creative.
    • Knowledgeable in product licensing activities such as premarket approvals (Canada NPN, AUST, etc) and notifications (US FDA, EU and Asia markets).
    • Assist with marketing collateral review in all the countries that Arbonne does business in.
    • Assist senior officers in the company by giving inputs and analyzing previous recorded data.
    • Respond to raised questions quickly and be knowledgeable of all the appropriate points and basics of the subject matter in question
    • Regulatory research for most current and updated food laws

    Qualifications

    • Bachelor’s Degree (BS) Food Science and Nutrition, Master of Science (MS) in Food Science and Nutrition preferred
    • 1-3 years’ experience in Regulatory Affairs within food and dietary supplements required

    Knowledge and Skills:

    • Understanding of Food & Drug Administration (FDA) policy and procedures required. Knowledge of international regulations including Canada, Australia, European Union, Asian and Latin American countries is a plus.
    • Access: Box, CRD, BaseCamp, Ithos
    • Strong Project Management experience required, Organizational Management, Cross-functional communication, Leadership
    • Must have a strong sense of ownership, accountability and the ability to inspire / encourage cross-functional teams to achieve collaborative success.
    • Strong analytical skills and hunger for perfection
    • Excellent communication skills, both oral and written
    • Ability to multi-task and set priorities
    • Basic computer skills: Must be proficient in Microsoft Word, Excel, Outlook and PowerPoint.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us

    Not ready to apply? Connect with us for general consideration.

    Discover Arbonne

    Thank you for visiting the Arbonne Career Site! As you can see, we are actively seeking amazing talent to join our growing team of dedicated professionals across various areas of the business.

    From Creative, Customer Service and Events — to IT, Operations, Product Marketing and much more — we proudly employ hundreds of dynamic, enthusiastic and positive people who work to make a difference every day. Our mission is to transform lives through pure, botanically based ingredients in scientifically tested products; a pure, healthy lifestyle; and the pure joy of helping others. We believe in the power of our people and our products to transform your life, and in turn, the lives of others. This is at the heart of what we do and who we are at Arbonne.

    If you did not find a current listing for a role that might suit you, we hope you will take a moment and upload your resume for us to keep on file in consideration for future job openings. We will then add you to our email database and automatically keep you informed about new positions and related updates. We would love to stay in touch!

    About Us

    Founded in Switzerland in 1975, and brought to the U.S. in 1980, Arbonne International creates personal care and wellness products crafted with premium botanical ingredients and innovative scientific discovery. Arbonne’s personal care and nutrition formulas are vegan certified, cruelty-free, formulated without gluten, dermatologist–tested and adhere to a strict Ingredient Policy. Arbonne products are available at arbonne.com or through an extensive network of Arbonne Independent Consultants in 7 countries: U.S., Canada, Australia, Poland, New Zealand, Taiwan and the United Kingdom. Arbonne is a privately held company headquartered in Irvine, California.