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项目适应症注册上市为目标,负责带领项目团队:制定相应的研发策略/计划并执行;识别过程中的潜在风险并制定、执行相应的风险控制策略;发现并解决过程中出现的问题;确保产品按时限、按计划成功注册上市
我们的客户是一家成熟型上市药企,目前在国内和海外同时开展临床试验, 专注在疫苗领域。
My client is a market leader with their Orthopedic Device Products with expansion plans in Asia. We are hiring a Team Head position in Asia to be responsible for Regulatory Affairs and Quality Management.
You will lead a project team and be responsible for the medical device business landing and launching program in China market from regulatory, safety, claims aspects.
The China Regulatory Affairs Manager will provide leadership and strategic direction for the Regulatory department in China. They will ensure that all local regulatory requirements are met throughout product lifecyle, from guiding formula development and innovation, to reviewing marketing/advertising materials such as labels and securing advertising permits, to handling post-launch reporting.
Est.1981, mature enterprise who delicate into the bee product head down;Servicing domestic and international clients with various products covering food&beverage, personal care, health & nutrition, animal care, and different types of OEM/ODM depending on requests
Full cycle Regulatory Affairs support from plant to end product;Provide RA advice for NPD;Cross function prepare related documents including but not limited to labels and raw material list;
Report to the Board, comprehensively preside over the daily operation and management of the company. Achieve the company's listing goal.
As China RA Head, report Global senior RA VP, work with global team to get involved in compound development strategy, clinical development strategy and RA strategy.
As RA Head, responsible for full RA job from strategy to project operation.
Managing complete drug variations