Regulatory Affairs Manager

Company: Melaleuca:The Wellness Company
Location: Salt Lake City
Posted on: May 15, 2022

Job Description:

"Enhancing the Lives of Those We Touch by Helping People Reach Their Goals"
For over 32 years, Melaleuca has taken this mission statement to heart. It is our guiding principle. Everything we accomplish is done with an eye toward promoting the physical, environmental, financial, and personal wellness of those around us. We are a dynamic, high-growth U.S. based CPG company that manufactures and sells effective, high-quality, natural, health-oriented products. We help people live more vibrant, healthier, and happier lives. When you walk through the doors at Melaleuca, you can feel it immediately. This is The Wellness Company.

We have an established history of consistent and profitable growth, with our annual revenues in excess of $2 billion USD. We now have over 5,000 employees worldwide and offices in 11 countries. Melaleuca is positioned to grow even more rapidly in upcoming years. To keep up with this growth we are looking for an outstanding Regulatory Affairs Manager to join our team.

Who you are
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. To be considered for this role you will have a proven track record of effectively leading regulatory processes globally. You are an expert in leading and developing a regulatory program . You are driven for success and want to help others achieve their goals!

Responsibilities
Other essential job duties are:
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
To be a good fit for this opportunity you will have:
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 five 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

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