職位描述
Position: Manager, China Regulatory AffairsLocation: Shanghai, ChinaReport to: Director of Regulatory AffairsKey Responsibilities: ?Develop regulatory strategy and action plan for internal or external projects, in compliance with local regulations, and guidelines and SOPs.?Compile registration dossier and ensure timely regulatory submission. Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.?Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing. ?Collaborate closely with internal groups and external clients in developing R&D strategies and/or commercial strategies.?Provide regulatory expertise to the R&D projects including biologics and small molecular drug products.?Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Coast Drug Control Institutes).?Continuously monitor the development of regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly evaluated and well communicated.Qualification: ?Medical/pharmacy/life sciences background, B.S. or above?Over 5 years regulatory experience in a globe leading pharmaceutical company?Strong network with regulatory agencies, e.g. CDE, CFDA, NICBPB?Be familiar with regulations and guidelines in CFDA, FDA and EU?Excellent communication skills and convincing skills in both Chinese and English?Good leadership and project management skills?Good team player?Open attitude, Willing to meet challengesQualified candidates are welcomed to send your CV to hr@wuxipra.com .
