Associate Regulatory Affairs Manager

1 month ago

Beijing, China GSK Full time
工厂名称: 北京
发布日期: Apr 8 2024

Role Purpose： 

To provide strategic and technical regulatory support to line manager for the purpose of commencing and maximizing GSK China Rx business by facilitating the submission and approval in a timely and high-quality manner in Infection Disease (ID) therapeutic area. 

 

Key Accountabilities/Responsibilities： 

  • Provide 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 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 NDA/CTA/Renewal/Variation to be approved and life-cycle management. 
  • Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to responsible products. 
  • 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, etc. 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 as needed. 
  • Ensure timely and flawless implementation of company SOP and compliance requirement in daily work. 

 

Qualifications/Requirements: (Education / Experience / Competencies) 

  • A minimum of bachelor’s degree in chemistry or biological or pharmacy. 
  • Minimum 4 years’ experience in regulatory affairs field and at least 3 years in MNC. 
  • Proven ability to communicate (written/oral) with various functions and with authority. 
  • Fluency in English. 
  • Ability of cross functional co-operation. Strong ownership and cross boundary working mindset 
  • A strong capability in problem solving. 
  • Strong ability of lobby, influence and negotiation. 

我们的目标是成为全球最具创新精神、业绩最佳、最值得信赖的医疗保健公司之一。我们相信，我们所有人都为 GSK 带来了一些独特的东西，当我们把我们的知识、经验和风格结合在一起时，将会实现令人难以置信的影响力。欢迎加入 GSK，您将受到启发，为我们的患者和消费者提供最好的服务。在这里，您可以做你自己，在愉悦的工作环境中不断发展进步。

  

面向职业介绍所/就业机构的重要通知

  

GSK 不接受职业介绍所和/或就业机构就本网站上发布的职位空缺所做的引荐。所有职业介绍所/就业机构均须联系 GSK 的商业及一般采购/人力资源部门，以取得事先书面授权，才可将任何应聘者推荐给 GSK。取得事先书面授权是职业介绍所/就业机构与 GSK 之间达成任何协议（口头或书面）的先决条件。在没有获得书面授权的情况下，职业介绍所/就业机构所采取的任何行动均应被视为未经 GSK 同意或在未达成合同协议的情况下进行。因此，GSK 无须就此类行动或职业介绍所/就业机构就本网站所发布的职位空缺进行的引荐所产生的任何费用负责。

  

致候选人的重要提示：

GSK 招聘团队只会使用 @gsk.com 后缀的邮箱与您联系。若您收到任何声称来自 GSK 邀请您面试或请您提供任何个人信息的邮件，我们建议您留意发件人的邮箱地址，并谨慎回复。若您不确定您所收到的邮件是否来自 GSK，请您通过 chk.recruitment@gsk.com 联系我们。

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