Responsibilities：

1、Participate discussion and assessment of development strategies for new oncology products, and contribute opinion and proposal for development plan;

2、Collect the updated regulatory requirement information, and consult to experts for their opinions, and reflect to the project team;

3、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;

4、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;

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

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

7、Well communicate and collaborate with DRA, DSCN related colleagues, and provide the opinions on regulatory requirements, protocol design and CSR preparation;

8、Conduct the 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 other related subjects. prefer candidates trained with drug innovation related courses;

2、5 years or above drug registration related experience, and 3 years above work experience in foreign pharmaceutical company;

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

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

5、amiliar with the use of Microsoft office;