Associate Regulatory Affairs Director社

面议

市辖区

发布时间：2023-09-06

职位描述

The Responsibilities:
- Lead China Regulatory Affairs Department, drive and implement the registration strategies and plans to ensure regulatory approval on RX and Consumable products;
- Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinate inspection of the organization and contract facilities and develop procedures to ensure regulatory compliance.
- Manage subordinate staff in the day-to-day performance of their jobs. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions.


The Qualifications:
- Bachelor degree above in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
- With 10+ years of relevant regulatory affairs experience with broad knowledge of the pharmaceutical industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.
- Have excellent knowledge of local regulatory system, needs to provide clear guidance and strategy to the team
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Excellent communication skills; both oral and writt*********************

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。