注册经理/副经理社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

职责描述：
? Develop and implement registration plan for new products in China within relevant therapeu-tic areas.
? Manage registration submissions for new products registration and clinical trial applications.
? Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
? Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
? Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.
? Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.
? Closely follow up regulation changes and analyze/predict its impact on company registration strategies.
? Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.
? Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.


任职要求：
? 5 years pharmaceutical industrial experience ideally; ＞4 year’s RA experience in pharmaceu-tical enterprise or CRO including more than 2 years in the project management post.
? Good knowledge of CFDA regulations and guidelines.
? Good working relationship with regulatory authorities.
? Good communication and management ski**********************

其他要求

招聘人数：1人
职能类别：

公司介绍

萌蒂（中国）制药有限公司（以下简称“萌蒂中国制药”）自1993年成立以来，始终专注于在疼痛领域的规范化治疗理念的推广和产品研发与生产。
萌蒂中国制药目前在华拥有1300多位员工，业务遍布300多个城市。在北京拥有设备先进、专业生产麻醉和精神类药品的工厂。
通过20多年的不懈努力，萌蒂中国制药已成为中国癌痛领域的领导者，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。
2018年3月，由国家卫生健康委员会扶贫办指导，《健康报》社、中国人口福利基金会健康报公益基金主办，萌蒂中国制药支持的“康萌大病救助计划”公益项目在北京正式启动，成为社会力量参与健康扶贫、大病救助的典范。
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抗呕吐、移植与免疫治疗、肿瘤、呼吸系统、健康消费品等全新领域，不断提供创新的产品，积极履行企业社会责任，为实现“健康生活，品质人生”的企业愿景而不懈努力。