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药品注册经理
3.5-4.5万
人 · 本科 · 5年及以上工作经验 · 性别不限2024/10/22发布
五险一金补充医疗保险通讯补贴专业培训年终奖金弹性工作定期体检周末双休带薪年假

远洋国际中心-A座

公司信息
赫力昂(中国)有限公司

外资(欧美)/1000-5000人

该公司所有职位
职位描述
Key Responsibilities,
1· Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
2· Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs
3· Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance
4· Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values, in order to present Haleon policies and strategies
5· Manage compliance within defined portfolio/activity streams in line with Haleon expections - support key processes and ways of working (eg, in relation to Haleon CMC, quality, product labeling requirements as well as local MoH regulations)
6· Work together with other functions ( eg, marketing, supply chain) to deliver NPD and value engineering projects
7· Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
8· Proactively manage impact of regulatory changes within defined scope of responsibility on the business
9· Maintain required regulatory compliance databases, systems and processes
Maintain high level of knowledge on the science of products within defined portfolio

Job requirements,
1.Position requires practically-applied demonstration of intellect and an ability to interface effectively with R&D, Quality, supply chain and commercial counterparts with credibility
2.5 to 6 plus years’ experience in Drug Regulatory Affairs, preferred import drug registration experience. Nice to have Medical Device experience.
3.Good knowledge in regulations.
4.oversight of the defined products requires a strong background in medicines.
5.Good communication skills, stakeholder management, matrix team management; Fluent English

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