Excellent job opportunity with Eli Lilly

朵拉的山野

一家全球大型制药公司招聘海外留学生或者学者，职位如下：
1>CMC Regulatory Affairs Mgr/Sr. Mgr; 2> Therapeutic Area Leader (TA leader)-Diabetes. Welcome to contact by gabrielguo@yahoo.cn。

JD如下：
Division:        Regulatory Affairs       

Reports to:Regulatory Affairs Director (RAD), China

Purpose:

•        Play the role as CMCin the team to facilitate the CMC strategy and technical communication;
•        Participate in registration strategy discussion, support and coach CN RA colleagues in implementing the planned registration action when necessary;
•        Compliance with applicable policies, procedures and other regulations.


Responsibilities:

•        Timely communicate and update to global counterpart regards CMC related requirements in China ；
•        Join new product development strategy discussion by providing expert inputs related to CMC issues if necessary
•        Facilitate RA team to solve the technical difficulties in product registration, F2F meeting with CDE, any CMC relevant questions from CDE, Sample testing in SFDA Labs, etc
•        As CMC/TA expert, ensure good quality of CMC data in CTA/NDA submission
•        Keep good communication and relationship with key stake holders internally and externally;
•        Work as a China CMC advisor to support colleagues in CN RA colleagues, Global RACMC to develop CMC strategies as needed
•        Provide support to CN RA colleagues to write quality overall summary for submission as needed


Qualification:

1.        Master/PhD degree in pharmaceutical or chemical/biopharmaceutical sciences
2.        Strong scientific expertise relevant to drug development and CMC related guidance.
3.        At least 2-year experience in drug development in global pharmaceutical company
4.        Good command of English writing, speaking and listening skill
5.        Self-motivated and Innovative

朵拉的山野

此工作地点是在中国。