Melaleuca Sr. Regulatory Affairs Manager in Idaho Falls, Idaho
“Enhancing the Lives of Those We Touch by Helping People Reach Their Goals”
For over 35 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 Sr. 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!
Regulatory knowledge and experience in food/dietary supplements, and/or cosmetics, home care chemicals, OTC.
Manages regulatory affairs mainly for the markets of the United States and Canada to meet compliance requirements of new product launches and maintain existing product supply, including product registration, notification & classification, regulation monitoring, risk analysis and advising.
Responsible for the management of new market launches from initiation of regulatory matters through implementation, including regulation research, timeline management, dossier creation, submission, correspondence with consultants/government authorities, and renewal filings.
Acts as Regulatory subject matter expert and adviser to Marketing, Operations, R&D, and QA regarding formulation, labeling, marketing, customs matters, and other regulatory issues that may arise. Works with local country executives/staff, external regulatory agencies, and consultants.
Reviews labels and marketing materials and recommend regulatory-compliant and marketing-appealing language to maximize marketing opportunities and claims.
Conducts legislative interpretation of government regulations, guidance documents, and standards for the markets to provide comprehensive analysis and recommend preventative measures.
Presents status reports, issues, & strategic regulatory analysis for management's decision making and strategic planning.
Briefs other members of the regulatory team on issues and changes that impact global regulatory matters.
Advises stakeholders such as the R&D and QA team on regulations that are vital to the company’s product innovation and quality system.
If needed, trains new employees to help efficiently utilizing internal human resources.
Competent regulatory knowledge and analytical skills of food/dietary supplements, and/or cosmetics, home care chemicals, OTC. Legal background preferred. For North American Markets with an emphasis in USA
Strong organizational skills, especially in the creation and maintenance of product dossiers and filing systems.
Strong project management skills, cross-functional task management, critical thinking, and analytical evaluation.
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.
Willingness and capability to accept assignments in support of the company and department goals.
Must be able to handle a high workload in an organized and efficient manner. Ability to work well under pressure and with others.
Proven ability to manage projects across international markets, time zones, cultures, and functions.
Periodic travel may be required.
Proficiency with MS Office, MS PowerPoint, Excel, and Outlook.
This can be a remote position.
External Company Name: Melaleuca, Inc.
External Company URL: http://www.melaleuca.com
Street: 4609 W. 65th S.