长沙招聘

RESPONSIBILITIES:

？ Implement registration plan, prepare and submit registration application on schedule.

？ Prepare QC validation testing materials and related dossier, and follow up test process to ensure timely complete.

？ Follow up with area EU/regional RA contact for required registration dossier, track registration process and make projects going smoothly.

？ Design and modify Chinese artworks for package insert, pack and label of marketed product based on relevant regulatory regulations, track progress to support commercial needs.

？ Review promotion materials according to the internal SOP; other assignment to effectively support commercial needs.

？ Maintain internal regulatory system to ensure clear record and archive.

？ Assist RA manager/RA Director to complete other assignment in a time manner.

Requirements:

？ At least 2 years working experience on position of drug regulatory affairs in pharmaceutical industry.

？ Good knowledge of CFDA regulations and technical guidelines.

？ Ability to communicate effectively across function and external association.

？ Demonstrate diligence and attention to details.

？ Pressure bearing capability.

？ Good command of written and verbal English.

？ Good command of office software.

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。