注册经理/高级注册经理

到岗时间：不限 年龄要求：不限 性别要求：不限 婚况要求：不限
Work with direct supervisor an d functional leaders （clinical, regulatory affairs, safety, CMC, external consultants, etc） to develop and/or manage NDA submission timeline.Facilitate direct supervisor to manage and/or coordinate the activities of NDA submission package preparation an d monitor the progress of NDA enabling activities.Facilitate senior managers to identify potential issues of the NDA enabling activities an d help to form action plan to solve the issues an d ensure NDA submission on schedule. As the eCTD responsible person to work with eCTD vendor to manage the NDA submission package preparation, publication, an d submission to CFDA职位要求：
Minimum of a Bachelor degree, preferably in a scientific discipline. 2. A minimum of 2 years of Project Management experience （preferably combination of general PM, clinical PM experiences, and/or regulatory affairs PM） in pharmaceutical companies and/or contract research organizations 3.Excellent communication skills with the ability to interact with all levels of management an d different functions （clinical, regulatory, safety, CMC, consultants, etc）. 4.Excellent organizational skills, detail oriented, an d goal driven 5.Knowledge an d experience of NDA submission, esp in eCTD/CTD format is preferred