
RA Project Manager

职位描述
Job Description
As a RA contact person to drive the regulatory input and support on the new import drug projects.
Work closely with the relevant stakeholders including PMO, BD, R&D, MA, Commercial, etc.
Support new project RA assessment if needed.
Responsibilities:
Being a RA Project Manager, the professional in this position will fulfill regulatory responsibilities including but not limited to the following:
Establish a thorough submission plan with strategic thinking for each assignment within the timeline agreed by stakeholders;
Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance.
Ensure regulatory/legal compliance of regulatory activities.
Liaising with the relevant governmental bodies and regulatory authorities, such as NMPA, CDE, NIFDC, etc..
Qualifications:
Bachelor degree or above, major in pharmaceutical or related major;
At least 5 years of experience in pharmaceutical industry;
Excellent knowledge and competency in Drug registration and relevant technical guidelines.
Good communication skill, creative thinking, with teamwork spirit; Result and detailed oriented and able to work under pressure to meet tight timelines
Good written and spoken English + Mandarin
Good Computer skill.
企业简介
[展开全文] [收缩全文]
职位发布企业

该企业其他职位更多>>
相关职位推荐
- 广州 医药代表
- 龙岩 医药代表
- 柳州 医药代表
- 上海 学术代表
- 太原 全产品事业部-学术代表(山西)(019703)
- 呼和浩特 全产品事业部-学术代表(内蒙)(019704)
- 南京 CDMO业务副总监/总监
- 南京 原料药CDMO业务高级经理/副总监
- 茂名 医药代表
- 玉林 医药代表