Regulatory Affairs Coordinator

(1 position)

Job description:​

1. Coordinate with suppliers and other relevant departments to get all the requirements for project screening both in regulatory and marketing fields.
2. Manage the derived information, do preliminary screening and present the report to    regulatory affairs manager for project potential determination.
3. Support clearance activities i.e. submitting the authorization letter, preparing translated CoA etc.
4. Work collaboratively with product manager or other relevant persons to build up product
   safety profile and report to TFDA, if necessary.
5. Responsible for all license renewal and drug report.
6. Do any relevant jobs as assigned.

Qualification:

1. Bachelor degree in pharmaceutical science or science in chemistry or biotechnology field.           
2. At least 0-2 years of experience in pharmaceutical regulatory affairs is preferred.
3. Good commands in English(both verbal and written),computer literacy and communication skills.                    
4. Prioritized, organized, multi-tasked and problem solving skills with being responsible and enthusiastic. 
5. Ability to work independently or as a team.