Major Accountabilities



1. Manage China DRA registration documentation archiving system(Reg. Dossier, Certificate, CDs, Label…)

2. Translation vendor management

3. Coordinate CPP/Certificate/Sample order with India DRA Hyderabad

4. Support the team on DRAGON Compliance Check to fully meet global target

5. Support franchise team to upload CTA/NDA submission to REDI

6. Support franchise team on PSUR submission on-line. Monthly track PSUR/RMP submission & approval status.

7. Archive PI and tracking BPI updates/approval, upload to Medical & Marketing Master Tool

8. Compile DRA monthly report with updates from DRA Franchise Head

9. ute daily operation compliance with DRA SoPs/ICC/ACC/NVS code/NP4

10. Logistic support to DRA face to face meeting with Health Authority and projects ad hoc.

11. Manage translation vendors to meet the quantity and quality targets.

12. Arrange DRA new staff on-board training and provide training on the application of DRAGON/xEDIs/AQWA, SOP and working process.



Ideal Background

Education:
Bachelor degree in Life Sciences, Pharmacy, Chemical, English, Archiving Management or equivalent experience

Languages:
Good spoken and written English and Mandarin



Experience:













Skills:
1. A minimum 2-3 years of working experience in archiving management and project management in pharmaceutical industry is preferred.

2. Experiences of working and communication with cross-functions in local and global

3. Have good skills on software application and database



1. Skills for planning and organizing

2. Good communication skills ( Verbal& writing)

3. Team player and willing to support others

4. Willing to learn and quick to learn

5. Carefulness orientation