RA Manager社

面议

市辖区本科及以上5年及以上

发布时间：2023-08-19

职位描述

• Review, compile, and submit IND, CTA, BLA applications, supplements and amendments;
• Provide regulatory inputs for new project development strategy discussion;
• Accountable to supervise the direct reports on the implementation of the project regulatory strategy by projects planning and tracking, and project executions;
• Accountable for achieving the target timeline of submission and approval;
• Accountable for the communication with Health Authorities (HAs) to properly address the concerns on projects; and the coordination of related HA meetings;
• Maintain a good relationship with HAs;
• Communicate with internal cross functional team on the related regulatory issues on the responsible projects;
• Accountable to provide regulatory support to other functional team;
• Accountable for ensuring regulatory compliance for the responsible project-related activities, like, maintenance of CTA-related submissions, and give input to relative WIs or SOPs updates;
• Monitor regulatory changes and report to department head timely;
• Provide/Assist department head to coach the junior levels;
• Other appointed tasks.

Job Profile:
. At least 8 years of life science industry experience post bachelor’s degree, with at least 5 years of demonstrated accomplishment in RA field;
Or at least 5 years life science industry experience post Master’s degree;
Or at least 2 years life science industry experience post Doctor’s degree;
. The experience in filing and obtaining approval for local or global trial IND/CTA
independently;
. Skills of cross functional communications within the company;
. Experience in HAs interactions;
. Experience with SOPs and WI updates;
. Experience in biologics such as mAb product submission is a plus;
. Experience with electronic submission is a plus;
. Experience with CRO management is a plus;
. The experience in filing and obtaining NDA/BLA approval is a plus.
. Bachelor or above with Pharmaceutical/Medical/Science background
. Fluency in English and Chinese (oral and written)

其他要求

招聘人数：1人
所属部门：Regulatory Affairs
汇报对象：RA Director
语言要求：普通话、英语
职能类别：知识产权/专利/商标

公司介绍

职库立志成为全球最顶尖的跨文化人才职业发展的人力资源专家，最专业的中国企业国际化战略的人才顾问，最活跃的国际化人才的社交互动平台。