Arbonne International, LLC

  • Regulatory Affairs Specialist 1

    Job Locations US-CA-Irvine
    Posted Date 1 month ago(10/17/2018 1:21 PM)
    ID
    2018-4052
    # of Openings
    1
    Category
    Regulatory Compliance
  • Overview

    The position of the Regulatory Affairs Specialist 1 reports to the Sr. Manager, and is responsible for the development, retrieval and maintenance of regulatory submissions.  This position will work closely with the Sr. Manager in the preparation of submissions (notifications & registrations) for new products, product changes, as required to ensure continued compliance, and timely approval for market release of products.  This position will work on cross functional International teams to launch and maintain compliant nutrition products in the US and International markets. Regular outputs include ingredient and formula reviews, label development, as well as document review.  This position will maintain knowledge of current/pending future regulations for ingredients, products, packaging, labeling, claims, and related areas for product lines and markets as assigned.  

    Responsibilities

    • Create and implement strategies with Sr. Manager or with multifunctional teams for International regulatory submissions.
    • Assist in the drafting of product registrations in worldwide markets for line extensions and new product releases. These product registrations may include current markets such as U.S., Canada, Australia, European Union, and Asia.
    • Support each affiliate/distributor on a case-by-case basis to address product registrations, custom requirements, and negotiations with ministries of health in each respective country.
    • Helps to coordinate with inter-department team members in the creation, update, maintenance of all Domestic/International technical files and dossiers.
    • Assist in the development and implementation of procedures for Domestic and International Regulatory Affairs.
    • Provide on-going support to all levels of Team Members, not limited to Product Development, Quality, and Marketing to facilitate required projects.
    • Assist Quality team during inspections/audits by the notified body or other International regulatory bodies by producing requested documents or answering any inquiries for information.
    • Assist in the creation and maintenance of an International Ingredient Database as a reference for Regulatory and other departments of ingredient’s acceptability within a country.    
    • Responsible for the periodic file maintenance of product registrations, submissions, manufacturer information and GMP status related to Nutrition products.  
    • Assist the Sr. Manager in the review of formula ingredients, artwork, artwork maintenance, label claims and substantiation for compliance.
    • Prepares and submits periodic reports, as required and performs special tasks and assignments, as required. 

    Qualifications

    Training and Experience:

    • Bachelor’s Degree (BS) in Nutrition, Food Science or Molecular Biology preferred. An MS degree preferred, but must have a degree in either Nutrition or Food Science.
    • Successful candidate must have at least 1-3 years’ experience in Nutritional products.

    Knowledge and Skills:

    • Thorough understanding of FDA (Food & Drug Administration). Knowledge of other International regulations including Canada, Australia, European Union, and Asian countries is a plus.
    • Must be proficient in Microsoft Word, Excel, Outlook and Powerpoint.
    • Knowledge of Food and Dietary Supplement Regulations, Australian TGA Listed Medicines, Canadian Natural Health Products and EU Food Supplements.
    • Excellent oral and written communication skills
    • Attention to details, work with less supervision, and able to maintain project deadlines.
    • Ability to multi-task and prioritize work.
    • Scientific background in chemistry, biology, biochemistry or molecular biology together with Food Science and Nutrition.
    • Master's degree preferred
    • Research and writing experience

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    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.