职位信息
Have overall responsibility for the management of the regulatory staff and regulatory functions and resolution of product related issues in China markets. Ensure that government approvals of foods, health foods, cosmetics and household consumer products in the local markets are obtained in a timely fashion and importation issues are resolved. Interact on a regular basis with government agencies and industry officials and other stake holders, as well as US corporate and country offices on regulatory issues affecting company’s products, and their importation, sale and promotion. Monitor and offer operational solutions to new legislation, changes to regulations and import policies. Manage compliance of health claims and other promotional materials distributed in the markets.
 
Essential Responsibilities and Duties
 
 
 
？Interpret laws, regulations, government policies and industry standards, and determine requirements and specifications that apply to foods, health foods, quasi drugs/OTCs, cosmetic and house hold cleaning products ; review ingredients and formulas and recommend most preferable classification for products, claims and labeling; resolve issues and prepare dossier.
 
 
 
Provide planning and accomplish notification, registration and other processing for foods, health supplements, quasi drugs/OTCs, cosmetics and household cleaning products with relevant government agencies, for imported and domestic products; work with and manage productive relationship with external consultants to successfully obtain registration of products in a timely manner;
Review product labeling, health claims, promotional publications and website for compliance with regulations; work with Marketing for competitive positioning of products, communicate risks and offer solutions.
Maintain status reports and timelines for products and projects, provide regular update on timeline and regulatory issues, and effectively coordinate with US Home Office personnel to accomplish registration or renewals in a timely manner; avoid stock-out situations;
Maintain effective working relationship with government and non-governmental agencies having jurisdiction over products such Chinese CFDA, AQSIQ, CIQ, SAIC, Taiwan TFDA, DOH, FTC, CPC, EPA and Hong Kong Center for Food Safety and DOH etc., testing organizations and industry associations; and monitor impact of consumer advocate groups affecting sale of products.
Closely monitor industry and regulatory developments, and media reports; evaluate government enforcements or new regulations and standards, and develop measures to minimize negative impact on Melaleuca products.
Continuously monitor government or non-governmental enforcements, media and industry practices affecting company’s businesses and industry in general and proactively update and recommend actions for compliance, risks as well as businesses opportunities.
Provide GMP guidance and other regulatory and testing requirements for company products manufactured in-country or abroad; interact and negotiate with vendors on company’s behalf to ensure compliance.
Work closely with US and country Logistics Departments and provide documentation requirements for customs clearance for importation of products into local markets. Ensure that the interfaces between Regulatory and other departments are managed optimally.
Communicate and offer solutions to regulatory issues in cross-functional settings regularly, assist Marketing, R&D, Manufacturing, Regulatory and others in developing new products, launch initiatives, and offer plans to implement registrations of products in accordance with market launch plans