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招聘职位: 国际注册专员
招聘人数: 1 职务类型: 其他类
发布时间: 2018-02-14 有效期: 60天
职位描述介绍
Job Description
Regulatory assessment for registration projects.
Overall responsibility and comprehensive insight into vaccine products registration in charged.
Independently work with International RA team to initiate product registration in target market.
Capable for take care multiple complex registration projects.
Communicate internal and external on product registration issues.
Basic knowledge of vaccine production process, QMS, clinical and nonclinical studies.
Assisting site inspection by foreign NRA and preparing responses accordingly to the outcomes.

Qualifications:
Minimum with bachelor degree in Pharmacy, Biotechnology or Immunology, at least 1 years similar working experience Biopharmaceutical or related field (Master degrees preferred)
Good understanding of regulatory issues (familiar with current regulatory affair & with product registration progress/procedure preferred)
Good communication, coordination and administration skills
Proficient of oral &writing in both Chinese and English.

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