• Regulatory Affairs Manager

    Position Type
    Full-time
    # of Openings
    1
    Category
    Legal
    Shift
    1st
    Location : Name
    Corporate Office
    Location : City
    Idaho Falls
  • Company Profile

    This is an exciting time for Melaleuca as we celebrate another record setting year!  We are a $2 Billion multinational company that manufactures, markets, and sells over 450 different products including: vitamins, supplements, sports nutrition, functional foods, laundry care, personal care, skin care, color cosmetics and enivironmentally friendly household cleaners.  We are experiencing record setting growth both domestically and internationally.  To help keep up with this growth we are looking for a talented individual to join our global Regulatory Affairs team.

     

    Overview

    This position is responsible for product registration, evaluation of foreign regulations, appraisal of product formulations, communication of regulatory requirements to various functional groups, development of regulatory dossiers, and coordination of regulatory and marketing activities within local markets while communicating closely with US-based teams. This position will primarily be responsible for the regulatory efforts required in our international markets with an emphasis on APAC, ASEAN & EU regions.

    Responsibilities

    Responsibilities:

    • Act as project manager over assigned registrations to ensure products are registered in support of market launch schedules.
    • Assures that existing and new products comply with all laws, rulings and regulations affecting the use of ingredients, labeling and advertising.
    • Monitors the development and assesses the impact of new and proposed changes in laws, rulings, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising. Submits comments on proposed changes to regulatory agencies as deemed appropriate. Communicates new requirements and changes within the organization, and assures compliance.
    • Coordinate with Melaleuca’s International regulatory consultants, and in-country resources to develop local language labels and marketing materials.
    • Helps identify and address potential patent and trademark issues in conjunction with in-house legal counsel.
    • Assures that exported products comply with appropriate international formulation, labeling, advertising and product registration requirements.
    • Assists Legal in researching and responding to issues related to litigation and other legal matters, as needed.
    • Provides guidance to Marketing on new product concepts, claims and formulations to assure compliance with FDA and FTC requirements.
    • Performs other related duties as assigned.

    Qualifications

    Desired Skills and Experience

    Minimum Qualifications:

    Education:

    • Bachelor Degree or higher in one of the Life Sciences.
    • Ability to analyze and evaluate complex legal and technical regulations.
    • 3 years' experience working in a regulatory and/or technical environment is desirable, particularly as it pertains to the dietary supplement field.
    • Strong organizational skills, especially in the creation and maintenance of product dossiers and filing systems for Latin America.
    • Excellent communication skills (written and verbal) for effective interaction with all levels of division, company and external business partners, with a demonstrated capability for cultural sensitivity and understanding.
    • Must be able to handle a high work load in an organized and efficient manner.
    • Proven ability to manage support of outside design firms and analytical laboratories.
    • Proven ability to manage projects across international markets, time zones, cultures, and functions.
    • Periodic travel may be required.
    • Proficiency with MS Office, MS Power Point, Excel and Outlook.
    • Ability to work well under pressure and with others.

     

    Experience:

    Requires at least one years of experience in regulatory affairs, with an emphasis on regulatory issues related to dietary supplements.       

     

    Knowledge/Skills/Abilities:

    • Comprehensive knowledge of laws and regulations pertaining to the manufacture and marketing of dietary supplements
    • Competent knowledge of nutrition and health sciences
    • Good analytical, organizational, and oral and written communication skills
    • Willingness and capability to accept assignments in support of company and department goals.
    • Familiarity with QA/QC processes beneficial.
    • Ability to oversee and provide advice through basic product reformulation processes.
    • Experience conducting technology transfer activities desired.
    • Proven ability to communicate in a multi-cultural environment especially while discussing complex, technical issues with non-scientific personnel.
    • Fluent in both written and spoken English. Additional foreign languages a plus.
    • Must have or be able to obtain a Passport which allows international travel.
    • Demonstrated success in project management, cross-functional task management, critical thinking, and analytical evaluation

    Certification:

    A certification from Regulatory Affairs Professional Society is preferred.

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