辉瑞

32.5万人浏览过  / 9人评价  / 268人正在关注   认领公司  

全球最大的以研发为基础的生物制药公司

Sr. Registration Officer 高级注册专员

工作要求

  • 工作地区:北京-东城区
  • 职位类型:全职
  • 工资待遇:¥ 1.5-2万/月
  • 工作地址:朝阳门北大街3-7号五矿广场

岗位职责/工作内容/岗位要求

工作职责:
Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
Keep close working relationship with HA officials and KOLs.
Interact with other functional team closely.
Ensure optimal regulatory compliance in China.
Primary Responsibilities

Collaborate and Communicate with China GEP and GIP President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:
Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
Closely follow up submission, QC testing, evaluation and approval in SFDA, CDE and official labs.
Keep communication with HQ and other internal functional teams.
Keep "alert" on regulatory intelligence.
Develop and improve good working relationship with HA and KOLs.
Report to line management regularly.
Maintain and update the Local Product Document (labeling) and Artworks in accordance with relevant regulations and Pfizer SOPs.
Partner with the global regulatory and clinical development team in GIP/GEP BUs for new products development strategy and inline products strategy.
Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
Partner with PGS for supply strategy to avoid supply issue due to site changes
Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices
Ensuring Regulatory Compliance
Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites
Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change
任职资格:
A bachelor degree major in chemistry, pharmaceutics, biology, medical or a related life-science discipline, or equivalent. A master degree or above is preferable.
At least 1.5 years drug registration experience in pharmaceutical companies.
Knowledge of drug development process, laws, regulations and practices affecting the pharmaceutical industry
Project management skill
Good skills on communication, collaboration, negotiation and problem solving.
Good English skill in both spoken and written.
Good computer skill.

以上内容仅为本站快照,最新信息请查看源网站

联系我们时,请说明是在职友集看到的,谢谢!

最近更新:
2019-11-18
来源网站:
前程无忧

收藏该职位

查看源网站>

举报该职位  |   免责申明  |   安全求职指南»

辉瑞

最新招聘(北京注册专员招聘)

不限经验 | 大专以上 | 面议
1.7万次浏览,
7小时前
更多 743 条职位,来自 1 家招聘网 >

北京Sr. Registration Officer 高级注册专员 • 薪酬概况与就业形势分析

¥9330 该数据为平均值,取自1330 份样本

截至 2019-11-22

查看分析报告
北京注册专员•就业前景分析
辉瑞Sr. Registration Officer 高级注册专员基本要求是什么?为你提供辉瑞投资有限公司Sr. Registration Officer 高级注册专员岗位职责,工作内容,岗位要求,还为你提供该职位竞争力分析,包括薪酬水平,学历要求,经验要求等。

快抓住这些工作机会

订阅 “北京东城区+Sr. Registration Officer 高级注册专员” 最新职位

信息举报

举报类型:
问题描述:
(选填)
邮箱地址:
(选填)

提交成功

感谢你的反馈意见!

匿名分享你的评价,帮忙大家了解该公司

1 2 3 4 5 一般 详细评分

500

我是该公司雇员: 至少需要再输入20

请以事实为基础进行评论,遵守法律规范,避免人身攻击等言论。