Career Category

Job Description

To lead the dossier preparation and submission to agency for all kinds of application (CTN/MAA/variation/notification/annual report) and ensure the submission of target.

Filing and submission:

• Lead submission in partnership with TA team
• Coordinate and follow the dossier package preparation with CMC team and cross-functions
• Analyze the gaps and needs for China RA in early phase submission
• Arrange dossier package printing and binding to ensure the submission on time
• Control the package filing strategy to facilitate simultaneous filing
• Be responsible for managing the archiving dossiers, certificate and approval letters

Project management:

• Learn and use all regulatory related system (e.g. RIM, LEXA, GRIP, RA China SharePoint)
• Being partner with all cross functions / global / region proactively manage and drive changes and implementation of enhanced regulatory quality processes to ensure China package being compliant with regulations, Amgen’s global and local policy, procedures, SOPs