Regulatory Operation Manager-Beijing

Job Summary

Focus mainly on filing & submission of CTNs / MAAs / variations

Optimize the working process to ensure efficiency delivery with high quality and compliance.​

Key Activities

Filing and submission:

• Independently lead submission (including CTN/MAA/Variation/Renewal/Annual report and RtQs) in partnership with TA/CMC team
• Be responsible for the management of submission dossier preparation with cross-functions (including coordinating the translation/proofreading), delivery of application submission and archiving of filings/approval files.
• Analyze the gaps and needs for China RA in early phase submission and generate the standardized document requirements
• Control the package filing strategy to facilitate simultaneous filing

Labeling management:

• Build/Optimize the China labeling life-cycle management process from label creation to maintenance; ensuring the compliance to China regulation requirements and Amgen process and SOP
• Localize the labeling process to meet the quick-turn around requirement during HA review in China
• Provide regulation insight and operational expertise to cross functions/regional/global teams; as the strategic partner to manage and drive changes and implementation of labeling files to ensure the compliance
• Support all post-approval label variations
• Be familiar with labeling system (similar with E2E system [LEXA]) to facilitate China label creation and maintenance tracking

Project management:

• Be expert in regulatory related system (e.g. RIM, LEXA, GRIP, RA China SharePoint)
• Organize the China RA internal project team meeting, tracking the project progress and escalating the flagged issue timely, to record the alignment via meeting minutes and follow up the post meeting actions till the solution
• Keep the China regulatory dashboard updated to reflect the progress of plan and achievement
• Being partner with all cross functions / global / region proactively manage and drive changes and implementation of enhanced regulatory quality processes to ensure compliance to China regulations, Amgen’s global and local policy, procedures, SOPs

Other activities as assigned by line-manager to support China regulatory team.

Knowledge and Skills

• Bachelor or above.
• 4-6 years industry working experience with documents submission.
• Local regulatory regulation knowledge
• Good communication skills, verbal and written in both English and Chinese, are imperative
• Good team player
• Computers: Microsoft outlook/ Microsoft teams/ Miro/ Word/ Excel/ Power Point/ Project