北京招聘

职位描述：
Responsibilities:
1.Develop and implement registration plan for new products in China within relevant therapeutic areas.
2.Manage registration submissions for new products registration and clinical trial applications.
3.Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
4.Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
5.Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.
6.Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.
7.Closely follow up regulation changes and analyze/predict its impact on company registration strategies.

Requirements:
1.More than 7 years pharmaceutical industrial experience ideally; >5 year’s RA experience in pharmaceutical enterprise or CRO including more than 2 years in the project management.
2.Good knowledge of CFDA regulations and guidelines.
3.Good working relationship with regulatory authorities.
4.Good communication and management skill.
5.Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.
6.Ability to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.
7.Understanding of market access needs and implementation of appropriate measures for health care purposes.
8.Strong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.
9.Ability to anticipate and facilitate issue resolution to meet local registration requirements. 举报 分享

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。