天津招聘

Accountability：

一、Collect, analyze and report China pharmaceutical regulation and policy, to help company to make the development plan of new products in China

1. Monitor the websites of drug agencies and other government departments, and collect and analyze the pharmaceutical regulation and policy, to make sure that any change of pharmaceutical regulation and policy will be found and clarified as early as possible.

2. Report China pharmaceutical regulation and policy to corporate management, development division and other relevant departments in ACN and API timely.

3. Organize to assess the impact of the change of pharmaceutical regulation and policy on company products or business. Communicate with relevant responsible persons and departments and make an explanation for potential issues caused by the change of regulation and policy.

4. Coordinate the relevant departments of ACN and API to provide the comments on the draft regulation and guideline.

5. Involve in the preparation and translation of monthly China regulatory news summary, and distribute to relevant departments.

6. Archive the Chinese and English versions of regulations/guidelines, database of regulatory news, feedback forms, result of impact analysis and other relevant materials. Keep above documents in the share point folder of Development RA department.

7. Responsible for the English translation and proofreading of regulation and guideline.

二、Collect and report the Japan regulatory update

1. Monitor PMDA website and Thomson Reuters Cortellis database to collect the update of Japan pharmaceutical regulation and policy;

2. Provide the Japan regulatory update for RDPAC Regulatory Intelligence Journal;

3. Based on the needs of drug agency and RDPAC, collect and provide the relevant Japan regulation and guideline.

三、Search and report competing products’information

1. Check the websites of CFDA and CDE, and GBI database. Search the status of the submission, technical review and approval of registration application of competing drugs, and timely report to Development RA department, and relevant departments in API.

2. Based on the needs of project team and API IP department, cooperate to search and investigate the information of competing drugs.

四、Manage the cooperation projects with stakeholders

1. Involve in the management of strategic cooperation projects between ACN and CCFDIE.

2. Assist to prepare the project plan and contract, and involve in the specific preparation and implementation of project.

五、Management of departmental SOPs

1. Keep and archive the original paper and electronic SOPs; periodically review the update status of SOPs.

六、Provide the supports for relevant departments

1. Provide the supports on regulatory policy for internal and external departments, to implement the business goals of Astallas.

2. Closely cooperate with development clinical dept., development medical dept., legal affairs dept., and corporate strategy dept. and related departments.

Qualifications：

1. Master or above degree in medicine, pharmacy or biology; have training experiences in regulatory policy, GMP, GCP, GSP, GLP etc.

2. Communicate fluently by using English; familiar with the office software, such as Ms Office, Outlook etc.; good abilities of communication and interpersonal relationship.

3. Have more than 3 years‘relevant working experiences in medical and pharmaceutical fields, and more than 2 years’working experiences in the joint venture companies.

安斯泰来集团介绍：

安斯泰来制药集团是一家总部位于日本东京的研发型制药企业，在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值，致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。
安斯泰来制药集团已经在器官移植领域和泌尿领域成为全球专业治疗领域领导者（GCL）。我们结合自身的研发实力，锁定了五个重点研发领域，包括免疫/感染、泌尿、肿瘤、神经科学和糖尿病合并症/代谢性疾病。
在2010财务年度 (2010 年 4 月至 2011 年 3 月) 全球净销售额达 9539 亿日元（97 亿美元）。安斯泰来已经成为日本第二大处方药品公司，全世界排名 20位的制药企业。目前全球员工约 16000 人。 如欲了解更多详细信息，请登录安斯泰来集团全球网站***********************/en/。

安斯泰来中国介绍：
安斯泰来制药（中国）有限公司（以下简称“安斯泰来中国”）是由原“山之内制药（中国）有限公司”于2005年8月更名，再于2007年4月1日，与“藤泽药品（中国）有限公司”合并而成。
安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念，秉持高度的伦理观和道德观，开展合乎法规的经营活动。在提升企业价值的使命下，发挥创造性，实现业务的持续发展，力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。
安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区，总部设在北京，在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司，业务范围遍及全国大中城市，全国约有员工1000名。
安斯泰来中国目前在中国上市销售9个产品，涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域，其中已经在器官移植和泌尿领域得到广大医生和患者的认可，处于市场领先地位。如欲了解更多详细信息，请登录安斯泰来中国网站**************************.