南通招聘

职位描述：
Purpose
? Support to establish regulatory strategy including renewal, variations and other site related regulatory activities based on Chinese regulation and guidelines
? Support to establish regulatory strategy of local manufacturing projects;
? Support MNT to solve Regulatory related internal and external activities/issues.

Responsibility
? Provide Regulatory expertise to develop RA strategy through all stages of drug product manufacturing according to the agreed timelines to get the approval in China including tech transfer and local repack
? Assess and communicate regulatory requirements with internal partners to ensure all submissions are in compliance with applicable regulations and guidelines;
? Prepare submission documents and submit applications on time, follow applications and communicate with health authorities to make sure applications could be approved on time.
? Update the internal stakeholders on the evolving regulatory requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;
? Cooperate with other stakeholders in different functions in MNT
? Keep good relationship with local Health Authority
? Other supporting work assigned by China RA Group.

Requirements
? Bachelor Degree or above in chemistry, biochemistry, pharmaceutical and biotechnology or equivalent;
? Over 1 year of experience in pharmaceutical product, proven practical knowledge of and ability to deal with routine regulatory issues and requirements;
? Excellent organizational, interpersonal and communication skills;
? Demonstrated leadership in cross-functional communication and alignment and ownership in resolving issues;
? Demonstrated ability for strategic thinking, maintaining awareness of business impact;
? Demonstrated alignment with cooperation values and culture;
? Fluent in Chinese and English (oral and written). 举报 分享

默克制药（江苏）有限公司
Merck – Living Innovation
默克 – 创新引领生活

默克是一家全球领先的医药与化工公司，以创新和高科技优质产品闻名世界。

默克在全球66个国家与地区拥有约38,000名员工，致力于改善患者的生活质量，助力客户实现长远的成功和迎接全球化挑战。

默克旗下四大业务分支——默克雪兰诺、消费者健康、功能性材料和默克密理博——2012年总收入达112亿欧元。

默克是全球历史最悠久的医药与化工公司。自1668年起，默克就成为了创新、成功和负责任的企业家精神的代名词。默克家族作为公司的创始人至今仍持有默克大部分的股份。

我们是默克，正根正源，在全球拥有“默克”这一名称和品牌的所有权。唯一的例外是在美国和加拿大，我们使用“EMD”的名称。

默克制药（江苏）有限公司位于江苏南通经济技术开发区，总投资6.5亿人民币，是默克在中国的第一家制药工厂，该工厂也将同时成为默克全球的第二大制药工厂。
该工厂将主要生产默克在中国国家基本药物目录中的品牌产品，包括糖尿病、心血管疾病、甲状腺功能失调等多种疾病领域—作为默克旗下最大制药公司，默克雪兰诺也是最早进入中国的跨国制药企业之一。
厂区首期占地4万平方米，第二期扩建2万平方米，2014年开建，2017年正式投入生产。

Merck – Living Innovation

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors.
Around 38,000 employees work in 66 count..ries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.
We generated total revenues of