上海招聘

职位描述：
Job Title: Regulatory Affairs Manager
Business Group/Unit: DNP / DFS
Service Group/Unit: Global Regulatory Affairs Quality Management
Reports to: Director of Regulatory Affairs China

The Challenge
Key areas of accountability/responsibility
? Leads/ Contributes to the joint efforts for the development of the global product approval strategy in a timely and accurate manner.
? Manage the Dossiers preparation for Product approval in collaboration with Product and Project Management based on the global regulatory affairs strategies of DNP and DFS. Adapt and submit the dossiers to the local authorities, follow up on the approval process
? Work with Product Management and production sites to prepare and maintain in order to secure compliance of company / product documentation to law while Quality Assurance & Product Management are accountable for the correctness of product documentation.
? Responsibility for global (e.g. JECFA) or regional (e.g. CRN; ERNA; FEFANA) representation, networking and shaping activities
? Provide input on changing regulatory environments and the related impacts on DNP/DFS business.
? Contributes to the development of DSM opinions in the areas of Regulatory Affairs and QM
? Support TQM for the product specific aspects in customer Quality agreements
? Issue management related to product quality aspects e.g. impurity CCR in close cooperation with all internal function (e.g. QA, Marketing & Sales, DSCM, PM)
? Representation of RA/QM aspects in the PPT meetings

Authorities
? Signing rights for statements on behalf of DSM (i.a. or i.V.; in specific cases ppa may be warranted)

Complexity of the job
? Regulatory Affairs / Product Quality Management is a cross functional activity with a high level of complexity based on the dynamics of global markets, different and changing global regulatory environments, public awareness and science focus of authorities and customers.
? Internally Regulatory Affairs / Product QM has to integrate input from Marketing and Sales (various industries and BU), SHE, Toxicology, R&D on a global level.
? To support the organization Regulatory Affairs Product Quality management has to provide easy understandable correct product information with regard to regulatory compliance and approval status of the portfolio.
? Provide guidance towards external customers concerning the interpretation of regulations / standards and implication on their business.
? Facing increasing requirements for the approval process Reg. Affairs Product Quality Management has to develop efficient, reliable and effective long-term strategies to achieve approval for the portfolio.

The Position
? Responsible for the product approval and maintenance of compliance in the different markets for the entire nutrition cluster. Advices/recommends to Marketing and Sales, Product Management, DSCM, Purchasing in all regulatory and quality related topics/issues
? Support of marketing and sales in customer contacts to RA and QM /QC related topics including alignment of customer quality agreements and CCR handling.
? Representation of DSM in industry associations working groups and supporting the local production sites in contact with local authorities.
? Globally the use of and the market approval for Food, Feed, pharma ingredients and Personal Care products is highly regulated and the requirements are very diverse between regions. To ensure that the DSM products are in compliance with these complex regulations, Regulatory Affairs /Quality Management advices / defines the internal requirements for new products to ensure efficient market clearances and compliance. This encompasses but is not limited to stability testing, heavy metal, residual solvent limits and other aspects in line with an in-depth HACCP assessment.
? Regulatory Affairs/ Quality Management further provides guidance and support for existing products in the context of production improvements, product changes or line extensions, new applications and changing regulations and deviations.
? Regulatory Affairs / Quality Management is the interface between the external authorities and the internal R&D, Safety, Marketing Units, and production sites. In this specific area of expertise Regulatory Affairs / Quality Management represents DSM externally.
? In the interaction with the DSM customers RA/QM provides a high standard consultation in areas of expertise and as such adds value to the business process.


The Ideal
? University degree in natural sciences or life sciences
? Recognized expert (in and out) and in-depth experience in the reg. affairs / Quality Area (at least 4 years).
? Knowledge on regulations and standards for DNP and DFS business
? Good language skills (English, local language where necessary, others appreciated).
? Team working skills
? Representing DSM in outside working groups as participant and in contact with officials from authorities and auditing units.
? Interdisciplinary knowledge in the areas Analytics, Chemistry and production process, Biology and Toxicology (basics and solid). 举报 分享

公司简介（中）：
帝斯曼在中国

荷兰皇家帝斯曼集团是一家以目标为导向，在全球范围内活跃于营养、健康和绿色生活的全球科学公司。帝斯曼不断推动经济繁荣、环境改善和社会进步，为所有利益相关方创造可持续的价值。帝斯曼为包括人类营养、动物营养、个人护理与香原料、医疗设备、绿色产品与应用以及新型移动性与连接性领域提供创新业务解决方案。帝斯曼及其关联公司约 23,000 名员工创造了约 100 亿欧元的年度净销售额。公司已在泛欧阿姆斯特丹交易所上市 (Euronext Amsterdam)。

帝斯曼早在1963年开始对华贸易，十几年前开始在华投资。帝斯曼中国地区总部和研发中心位于上海，目前在中国拥有共14个生产场地， 员工约3,000名。帝斯曼在中国业务正稳步增长，2009年在中国销售额约12亿美元。同时，帝斯曼也正一如既往地全方位融入中国的可持续发展事业。

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Bright Science. Brighter Living.
Royal DSM is a purpose-led global science-based company in Nutrition, Health and Sustainable Living. DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative business solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about 10 billion with approximately 23,000 employees. The company is listed on Euronext Amsterdam.
DSM began trading with China in 1963 and established its first China sales office and first manufacturing facility in early 1990s. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. The company currently has 40 affiliates in China including 26 manufacturing sites and employs about 3,500 people. DSM China regional headquarters and China Science and Technology Center are located in Shanghai.
DSM’s business is growing healthily and steadily in China with revenue of USD1.7 billion in 2012. In line with DSM’s global vision, we advocate sustainability via the partnering with a high growth economy while internally we embrace diversity and localization of management to empower local talent. We strive to be an Employer of Choice and take pride in attracting, developing and retaining talent by enhancing a forward thinking working environment with a high-performance culture encouraging collaborative action.
Are you ready for a Bright and Positive journey with us? Please visit our website and check out the career opportunities with DSM China.