Regulatory Affair Manager法规事务经理Greater China
赢创德固赛(中国)投资有限公司上海分公司
- 公司规模:500-1000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:上海-闵行区
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:药品注册
职位描述
Official Title: Regulatory Affair Manager法规事务经理-Greater China
Location: Shanghai Xinzhuang (shuttle bus provided)
Purpose of the position:
Defend company business interest in Chinese regulatory affairs
Responsible for coordination & preparation of regulatory submissions and strategies
Develop & maintain regulatory knowledge of Chinese regulation processes
Communicate and cooperate with regional ESHQ and ensure cosmetic raw materials can comply with government authorities’ regulations, standards and requirements;
Compile all necessary data and/or files for imported personal care raw materials registration.
Communicate and cooperate with registration authorities, BL headquarters, Essen and other agency to finish registration.
Build and maintain good relationships with relevant government authorities and industrial associations, participate in activities organized by government and associations;
Follow up new regulation and communicate regulatory issues with government and associations, provide regulatory suggestion and advice for personal care BL in China as well for as the BL on a global basis.
Complete other affairs assigned by the leadership basing on completion of these upon tasks.
Responsibility:
Manage Registration of EVONIK produced cosmetic ingredients, with SFDA, in order to allow sales or production of corresponding raw materials in China, for both the cases managed within Evonik, and the cases managed by external third party agents.
Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
Participate in product teams with regard to implementation of regulatory requirements
Coordination with ESHQ, to be aware of the status for new material registration with IECSC, and status of completing Chinese MSDS requirements, from the customers.
Entry point of all regulatory affaire related customer or distributor inquiries, organize response directly, or upon validation from global regulatory officer, or data generation from lab testing or by other means, in order to respond.
Collect information on registration instructions and regulations for Chinese registration process of cosmetic ingredients, provide prompt update to technical teams, as well as sales and marketing team.
Communication with global regulatory officer on regular basis, to obtain updates on product regulatory profiles, and support decision making for communication plan, for these information, to Great China region.
Requirements:
Good knowledge of Chinese regulations on cosmetic ingredients, and new material registration processes, and government requirements for the producers/importers/trading companies.
Mastered the tools to be aware and updated for any new policies, with good understanding of such changes and any impact to the product portfolio he/she is working on.
Familiar with testing method for material properties, including toxicity profiles, and physical/chemical properties, etc.
Good knowledge of personal care products, including understanding of its research methodology and manufacturing procedures in general.
Keep up to date with market trends and new developments utilising information for business improvement
Willing to work across functional and cultural boundaries.
Able to develop his/her network with local authorities/government, external vendors, and as well as internally with global team.
Working together with technical, marketing and sales team, corporate services departments, and his/her supervisions ensures him/herself is supported adequately on different tasks.
Recognise recurring issues and analyse their causes in order to reach a solution
Alert supervising person about decisions to be made, and the criticality of such decision.
Able and willing to come up with proposals which illustrate preferred options for decision making.
Good team spirit
Ability to discuss strategic and sensitive issues
Knows how to work with local authorities and government departments.
Skilled in net working, with vendors, with multi-functional teams, and with trade associations
Understand and develop long term business vision for SFDA registration
Willing to learn and also to share knowledge with other people
Be able to detect the problems, and solve it via logic and rational approaches, proactively.
Careful planning to achieve accurate and timely results
Bachelor or master degree, in chemistry related subjects, preferably, analytical chemistry or pharmaceutical chemistry.
Experienced in personal care products and materials registration, or in registration process of pharmaceutical products, also considerable. Preferably, 3 years + hands on experience obtained.
Familiarity with imported products registration and related regulations.
Fluent in English communications, solid skills both in written and in speaking.
Good at computer software uses.
Mini Education level: Bachelor
Major preferred: analytical chemistry or pharmaceutical chemistry.
Language skills: English Fluent
Minimum years in employment: 3 years
Preferred industry experience: in personal care products and materials registration, or in registration process of pharmaceutical products
公司介绍
Evonik, the creative industrial group from Germany, is one of the world leaders
in specialty chemicals. Its activities focus on the key megatrends health and nutrition, resource efficiency and globalization. In 2010 about 80 percent of the Group’s chemicals sales came from activities where it ranks among the market leaders. Evonik benefits specifically from its innovative prowess and integrated technology platforms. Evonik is active in over 100 countries around the world. In fiscal 2010 more than 34,000 employees generated sales of around EUR13.3 billion and an operating profit (EBITDA) of about EUR2.4 billion.
Evonik Industries has been producing specialty chemical products in the Greater China region (Mainland China, Hong Kong and Taiwan) since the late 1970’s; with wide-ranging trading relations already in place prior to this in the region. The Group now has a total of 18 companies and 15 production sites in the Greater China region with around 4,000 employees. The regional sales reached EUR1.23 billion in 2010.
Evonik regards Greater China as one of the driving forces of the global economy and we consequently endeavor to grow our business in the region. Evonik launched the "Greater China Growth Path” initiative in the fall of 2008, a strategic development plan with comprehensives measures for regional business development. Based on this initiative, Evonik has started a number of cross business unit projects for some key industries such as automotive, construction, electronics and lighting, etc. Several strategic investment projects are also under way in the region to ensure that the growth trajectory continues in the long term. Besides the investment into production facilities, Evonik also wants to strengthen its R&D efforts in the Greater China region by boosting local innovation.
Evonik regards people as the most important assets for our sustainable growth. Wherever possible, we aim to fill key positions with highly qualified local managers and offer them attractive career opportunities in the Group. In December 2010 the international publishing company CRF singled out Evonik as one of “China’s Top Employers 2011”, which is already the fourth time that Evonik China received this award.
赢创与赢创大中华区简介
赢创是一家来自德国的创新型工业集团,我们的核心业务 —— 特种化工在全球处于领先地位。我们将业务与全球大趋势相结合, 即能源效率、健康与营养、全球化科技发展。2010年,集团80% 的销售额都来源于市场领先的化工产品。赢创的发展得益于其创新实力和一体化技术平台。赢创的业务遍及全球100多个国家。在2010财年,赢创集团的34, 000余名员工创造了133亿欧元的销售额, 营业利润 (税息折旧及摊销前利润) 达24 亿欧元。
赢创工业集团自上世纪七十年代末期开始在大中华区(包括中国大陆、香港和台湾)生产特种化工产品,并早在此之前就在这一地区有了广泛的业务活动。目前,赢创在大中华区拥有18 家公司,15 个生产基地。2010年,赢创大中华区约有4,000名员工,总销售额超过12.3亿欧元。
赢创视大中华区为推动全球经济发展的驱动力之一,并为实现业务在大中华持续增长而不断努力。公司于2008年秋天启动了战略发展计划 “大中华区增长之路”,以全面推动发展本地区业务。作为这一战略的重要组成部分,赢创启动了针对多个主要市场的跨业务部门项目,如汽车、建筑、电子与照明等。为确保公司在本地区的持续稳定增长,我们也正开展多个战略投资项目。除投资生产设施外,赢创同样通过扩大本地创新活动,提升其在大中华区的研发实力。
人才是我们实现可持续增长的最重要资产,我们不断培养高素质的本地经理担任公司的重要职位,并为其提供在集团的职业发展机会。2010年12月,赢创荣获由国际调研机构CRF颁发的 “2011中国杰出雇主” 荣誉,这也是赢创中国第四次获得这一全球领先的人力资源奖项。
联系方式
- 公司网站:http://www.evonik.com
- 公司地址:莘庄工业区春东路55号
- 邮政编码:201108
- 联系人:Recruiting Manager