專案經理 (CMC/製劑專業)

작업 내용

The project manager is repsonsible for the technical transfer of the drug production for late-stage clinical supply to NDA submission. The project manager should be familiar with the requirement of the topical formulation, including the manufacture process, analytical method, material soucring and vendor qualification.

主要職務 Job objective:

1. Experts in the drug development, technical transfer and site transfer, IVRT method development in drug product, especially in topical product.

2. Preparing IND/ NDA dossier, mainly on CMC part and familiar with EU and FDA CMC regulatory requirement.

3. Work closely with external departments including CMC team(s), Clinical Team and Regulatory Operation to align with submission strategy.

4. Ensure that all projects are delivered on-time, within scope and within budget.

5. Monitor and manage development status and report internally and partners, if needed.

6. Troubleshooting and perform risk assessment to minimize any CMC errors.

7. Maintain database and allocation.

職務條件: