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更新于 10月24日
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Senior Regulatory Affairs Expert（Senior Manager Level）

4萬-6萬·13薪
  • 北京朝陽區(qū)
  • 慈云寺
  • 經驗不限
  • 本科
  • 全職
  • 招1人

職位描述

新藥注冊仿制藥注冊進口藥品注冊藥品注冊策略
The Job
? Provide strategic and technical regulatory support to line manager for the purpose of
commencing and maximizin China CEP business by facilitating the submission and
approval in a timely and high-quality manner.
? Play a critical role in providing strategic and technical regulatory input and support to line
manager to contribute for decision making on drug development strategy and license
maintaining strategy to deliver the highest value to business.
? Independently in charge of all CMC regulatory relevant activities for CEP products,
including CMC strategy making and implementation, CMC document preparation, CMC
technical communication, CMC issues solving, QC testing, ChP, bundling review, etc.
? Provide high quality, clear and concise strategy, and advice on general regulatory topics.
? Independently compile high quality filing document complying with external and internal
requirement to provide right and clear drug profile and data to NMPA to achieve targeted
labeling and drug features to be approved.
? Independently engage with internal and external stakeholders to follow up every milestone
closely to ensure issue identified, escalated, resolved timely and target filing and approval
timeline plan is achieved.
? Establish and maintain a good relationship with key regulatory authority in daily work
such as NMPA, CDE, NIFDC, CPC, via professional communication.
? Make sure line manager fully informed products registration status in daily work.
? Support line manager on budget planning and monitoring in daily work.
? Provide timely and high-quality regulatory support and input to internal key stakeholders
such as medical and commercial as needed.
? Significantly contribute or lead function continuous improvement initiative
? Ensure timely and flawless implementation of company SOP and compliance requirement
in daily work.

工作地點

遠洋國際中心

職位發(fā)布者

陳女士/合伙人

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