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博士后
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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 |
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