Registration Director

Job Responsibilities:

1. Be responsible for the collation, submission and coordination of pre-, mid-and post-declaration materials.

2. Participate in collating and summarizing the whole process of registration information to ensure the integrity of information.

3. Participate in the preparation of IND and cross-border ECTD documents, including part of module 1 documents, part of CMC Declaration documents and non-clinical review documents.

4. Be responsible for arranging pharmaceutical and registration application materials, tracking the progress of registration, timely communication and feedback, and according to the needs of the registration application materials to supplement, to ensure the smooth approval of registration matters.

5. Maintain good and timely communication with drug supervisors, researchers and related experts to build up a good corporate image.

6. To monitor the updating of drug registration related regulations, policies, guidelines, etc. ; to issue drug regulations and other related consultation drafts; to organize discussion among relevant departments.

7. Report to the immediate leader in time, and complete other tasks arranged by the superior.

Qualifications：

1. Bachelor degree or above in pharmacy, biology, cell engineering, cell biology, immunology, biochemistry, molecular biology, etc.

2. At least 3 years registration experience in biologics industry;

3. Familiar with biomedicine and innovation drug registration regulations, stem cell industry is preferred; Experience of participating in or successfully applying for drug registration is preferred.

4.Strong oral and written communication skills, execution, team spirit.