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MG-Regulatory Affairs Manager (美商)

發表於: 10 Oct 2017

Job Distribution:

  • 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 effective working relationship with government and non-governmental agencies having jurisdiction over Company products such Taiwan TFDA, DOH, FTC, CPC 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.

  • 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.

Qualifications:

  • 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.

行業: 法律
職業: 醫療保健/生命科學/生物/製藥產業
法律/專利
其他
工作地: 台北市
僱傭類型: 全職
工作經驗: 5
薪資範圍: 面議

For enquiries, you can contact Meg Yen for a confidential discussion.

Email: meg@recruitexpress.com.tw

Contact: 0287806822

**All information will be treated with the strictest confidence. We regret that only short-listed applicants will be notified.