CMC Specialist

Jobinhalt

• 新藥研發公司
• 準上市公司

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.584248