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Reg Affairs Assoc II

Req #: 1700090R_en
Location: Guangzhou, 44 CN
Job Category: Regulatory Affairs
Date Posted: 11/9/2017 12:51:05 AM
Baxter International

1.    Compile and submit, in a timely manner, registration documents (new registration/ license renewal/OEM registration/supplemental application) according to regulatory requirements. 根据法规要求按时整理和递交注册文件(新注册/再注册/OEM注册/补充申请)。

2.    Prepare, review, and approve label artwork.准备、复核和批准标签设计。

3.    Implement new registration standards in plant.确保新注册标准在工厂内得到贯彻实施。

4.    Provide registration related advice to project teams.为项目团队提供注册相关意见。

5.    Respond to registration related questions with strict deadlines.严格在期限内回复注册机关的问题。

6.    Ensure and word in compliance with all EHS aspects.确保工作符合环保、健康和安全的方针政策。

7.    Create and maintain friendly relationship with related government officer in China. 维护相关政府的关系。

8.    Responsible for employee’s regulation awareness improvement within the Plant.提高工厂内对法规的认知。

1.     Bachelor's or above degree in pharmaceutical, chemical, microbiological or related field.    药学、化学、微生物学或相关学科的学士或以上学位。

2.     3 years or above GMP & registration professional experience in pharmaceutical or related industry. 3年或以上药厂或相关企业GMP和注册的专业经验

3.     Thorough knowledge of applicable procedures, specifications, regulations and standards. 应具备应用程序、规范、法规和标准方面的知识。

4.     Good communication and management skill.   好的沟通和管理技巧。

5.     Good command of English speaking and writing.  良好的英语能力。

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