苏州 [切换城市] 苏州招聘苏州生物/制药/医疗器械招聘苏州政府事务管理招聘

Regulatory Manager(化学法规事务经理)

奥麒化工(中国)有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:石油/化工/矿产/地质

职位信息

  • 发布日期:2013-01-15
  • 工作地点:苏州
  • 招聘人数:1
  • 工作经验:八年以上
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位类别:政府事务管理  化工技术应用/化工工程师

职位描述

JOB PURPOSE(工作目标)

a. Make sure our products match China and Global Regulatory requirements to avoid illegal issues impact Company performances.

b. Update Products MSDS to our customer and our staff, ensure use it safety to meet RC requirements. Also meet the regulatory requirements.

c. Register new products to Chinese government for Business team to promote the sales performance.

d. Work with China Government and Industrial Association to take part in some new chemical standards and regulations draft.

e.Cooperate with Head Quarter Regulatory team to take care of the regulatory affairs in China.

KNOWLEDGE AND COMPETENCIES知识和能力)

  • QUALIFICATIONS学历与资格证书)

Bachelors/University degree and/or above in Science and Technology (Chemistry, Pharmacy related field is plus)

  • EXPERIENCE经验)

Minimum eight years experience in relevant area of regulatory and legal specialization, special in chemicals or Pharmaceutical related industry.

Need the regular professional training organized by China Government.

  • COMPETENCIES (能力)

Be familiar in GHS Label, GHS MSDS and Reach system, have successful experiences in new products registration processing, have good relationship with related government management organizations.


JOB OVERVIEW工作概述

1.Responsible for application of Arch’s products get into new market and registrations in China, such as, drinking water application permission in MOH, Disinfectants registration in MOH, New personal care ingredients registration in China FDA, New Chemical ingredient registration in China MEP etc.

2.Help Arch’s operation to understand and to meet Chinese regulatory and laws (i.e. GHS MSDS, GHS labels, etc.). Responsible for applying necessary certifications for Arch’s operation, such as, Manufacturing Licensing for Disinfectants Products, etc.

3.Set up and maintain the GHS MSDS and GHS labels for the products manufactured in Suzhou Plant, also take care of some imported products

4.Support Biz team and CSR team to answer/solve the regulatory issues come from our customers.

5.Work with China industry association in helping to develop industry standards and regulations to meet international standards, such as new industry standards and regulations for disinfection association, etc.

6.Update the latest Regulatory published by Chinese government to China team and Head Quarter.

7.Set up and keep good relationship with China Government, such as SFDA, MOH and MEP to make our registration work smoothly.

8.Support team for Patents and Trade mark issues.

公司介绍

苏州龙沙化工有限公司是前美国奥麒化工公司在苏州独资设立的子公司,占地面积为62414.8平方米。苏州工厂于2005年开始投建, 整个项目分为三期建成: 一期项目行政办公楼及活性酵母精华(TRF)生产车间与实验室;二期项目生物杀菌剂(锌奥米啶ZPT /铜奥米啶CUPT)干燥与制粒以及三期项目生物杀菌剂(ZPT/CUPT)的生产, 整个工厂于2008年建成并成功试产, 2009年通过关键客户的产品认可和批准, 继而开始整个工厂的规模投产及运营。苏州工厂于2010年通过 ISO9001质量体系认证。2011年,龙沙集团收购奥麒集团。 继此,奥麒化工(中国)有限公司正式成为龙沙微生物控制业务部的一家生产厂。
Suzhou Lonza Ltd., is the wholly owned subsidiary of the former U.S. Arch Chemicals established in Suzhou, covering an area of 62,414.8m2. Suzhou plant started construction in 2005 and the entire project was built in three phases: Phase 1 project is administrative office and active yeast extract (TRF) production workshop and laboratory; Phase 2 project is biocides (Zinc Omadine ZPT / Copper Omadine CuPT) drying and granulation as well as Phase 3 project biocides (ZPT / CUPT) production, and the entire plant was completely built in 2008 and succeeded in trial production, and in 2009 after product recognition and approval by key customers, and then scale production and operations were started in the entire plant. Suzhou plant passed ISO9001 quality system certification in 2010. In 2011, Lonza Group acquired the Arch Group. Then Arch Chemicals (China) Co., Ltd., officially became a production plant of LMC.

联系方式

  • 公司地址:上班地址:工业园区