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5-7年经验 -
本科 -
招1人 -
02-24 发布
职位描述
Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in China, aligned with China business strategies and plans.Provides guidance in aligning regulatory affairs in China to ensure synergy and integration among China, global/region and external partner, and ensuring strategic input into product-related activities (development and lifecycle).Provide leadership to ensure that sound regulatory practices are fully integrated in all pre-clinical, clinical and technical submissions and evaluate all documents submitted to regulatory agencies to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a manner that facilitates agency review.Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks; ensure that development and manufacturing activities meet all relevant requirements and guidelines.Provide regulatory intelligence related to medical device mainly but not limited to medical device.Provide regulatory evaluation for in-licensing opportunities.任职资格：Minimum 6-8 years working experience in regulatory affairs.In depth knowledge of the regulations affecting the medical device industry in China; including both pre-market and post-approval regulations. A history of positive working relationships with senior officials within major regulatory agencies and a track record of success in gaining drug/medical device approvals.Ability to interact effectively across boundaries with cross-functions.Well developed project management skills with the demonstrated ability to provide direction to others in cross-divisional project team environments and in matrix reporting relationships. High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.Ability to develop and implement strategic growth plans; ability to multi-task and to interact and negotiate with diverse groups on an international scope.Transparent communicator. Strong verbal, written, inter-personal, planning and organizational skills are required. 职能类别： 药品注册 关键字： 药品注册
联系方式
北京市建国门外大街中环世贸中心
公司信息
萌蒂（中国）制药有限公司（以下简称“萌蒂中国制药”），自1993年进入中国以来，始终专注在疼痛领域的规范化治疗理念的推广和产品研发与生产。目前，萌蒂中国制药是国内一家专业研发生产和推广镇痛药的跨国公司，在华拥有1500多位员工，业务遍布300多个城市。在北京拥有设备先进、国内的专业麻醉和精神类药品的生产工厂。 通过多年的不懈努力，萌蒂中国制药已成为中国癌痛领域当之无愧的领导者，并引领镇痛领域。 多年来，我们一直坚持为提高人类的生活质量和健康水平而奋斗，“健康生活，品质人生”是我们的企业愿景；关爱生命，回馈社会是我们的社会责任；创新的天赋，以患者为核心的理念以及企业家精神是我们血液中的 DNA。 未来，萌蒂中国制药将继续深耕疼痛管理领域，同时将业务进一步拓展至肿瘤、消毒用品、呼吸系统、健康消费品等全新领域。 更多公司信息，请参阅 http://www.mundipharma.com.cn
