Job Title: Sr. Regulatory Affairs Manager
Purpose of the Role and Job Summary
Have overall responsibility for the management of the regulatory staff and regulatory functions and resolution of product related issues in China, Taiwan and Hong Kong 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 company 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.
Knowledge, Qualifications and Personal Attributes
§A bachelor’s or higher degree or equivalent education in life sciences areas preferably in pharmacy, food/nutrition, biology or biochemistry, with at least 10 years of working experience with a multinational food/health food company doing business in East Asian countries; minimum 6 years of management experience. Familiarity with ASEAN and other regional harmonization initiatives is a plus.
§Management experience includes planning and leadership to the regulatory staff by ensuring that appropriate structures, systems and competencies are developed in line with company culture and successful teambuilding.
§In-depth understanding of international regulatory environment, complexity and trends, influence of international organizations such FAO, WHO and CODEX on Asian governments’ health policies and priorities, and legislative initiatives affecting the trade of above goods across Asian countries.
§Extensive knowledge of and experience in analyzing and evaluating complex legal and technical regulations and standards applicable to foods, health foods, cosmetic, OTCs, household cleaning and other consumer goods. Knowledge of chemical and environmental laws affecting consumer goods is a requirement. Ability to provide regulatory expertise to cross-functional and regulatory teams.
§Expertise in health claims regulations and consumer advertising standards applicable to all medium of messaging including worldwide web, social and interactive media and evaluation of scientific substantiation under food, drugs and consumer protection laws and standards, and risk management.
§Ability to determine appropriate classification, positioning and labeling of products, review nutrition data and other technical information on packaging for compliance, risks for non-compliance, for submission of labels to government agencies.
§Excellent knowledge of the industry, competitors market practices and government enforcement and ability to monitor, analyze and act quickly on regulatory and legislative changes affecting company’s products or labels.
§Experienced in analyzing the impact of draft legislation announced for public comments on company’s products and industry, working with industry peer groups, developing persuasive arguments and drafting and submission of comments to government agencies.
§Knowledge of customs rules and documentation requirements affecting importation of products and clearance process; negotiation experience with Customs authorities.
§Excellent problem solving and cross-cultural interaction skills and ability to influence others and maintain productive relationship with company’s offices in various countries, government agencies and industry officials, and effectively represent company and its products for government approval;
§A native Chinese (Mainland) fluent in English, with superb communication skills (written and verbal); ability to explain complex technical and regulatory issues in plain language.
§Ability to work on multiple projects simultaneously, and function well under pressure in fast paced business environment, and interact regularly across international time zones.
§Strong organizational skills, especially in the creation and maintenance of product dossiers, filing systems and project management.
§Proficiency with MS Office, MS Power Point, Excel and Outlook.