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注册事务(高级)经理

(2021-03-10)

第一三共(中国)投资有限公司

职位性质:  全职 工作经验:  不限 招聘人数:  1 工作地点:  北京
学历要求:  不限 语言要求:  不限 简历要求:  中文 薪资待遇:  面议

职位关键字:

Responsibilities:

1、Discuss and develop the registration strategies for new oncology products/projects, and contribute opinion and proposal for development plan;

2、Provide the opinion related to documents preparation, submission and review timeline on the new product development plan; develop the IND and NDA submission plan and timeline;

3、Complete IND and NDA documents preparation, QC check, submission, review follow up and approval, and timely reflect and resolve the issues during the review process;

4、Organize and promote the preparation, coordination, progression and completion of QC test, GCP inspection and GMP inspection;

5、Plan, Prepare and Organize CDE communication meeting and expert consultation meeting for new products;

6、Coach and instruct the team members for the work;

7、Well communicate and collaborate with DSJ-DRA, GRSL, CMC RA and PMRA, DSCN related colleagues, and provide the opinions on regulatory requirements, protocol design and CSR preparation;

8、Conduct the regulatory assessment for the changes during IND and post approval of new products, and develop the submission plan and implement and complete the review and approval process; timely prepare and submit the IDL renewal application and get approval;

9、Well follow the requirement of related regulations and guidelines; implement the global, regional and local SOPs; follow the instruction and direction of line manager;

10、Develop the good network with experts from authorities and industry; closely notice the regulation changes and its effect on company business;


Qualifications:

1、Master Degree or above, major in Medicine, Pharmaceutical Science, or Biology related subjects;

2、8 years or above drug registration related experience, and 5 years above experience of registration project management for oncology products or biological products; prefer to have the experience of bio-products registration. 

3、Fluent English listening, speaking, reading and writing;

4、Good communication and expression skills; good organization and coordination skills;

5、Familiar with the use of Microsoft office;


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