Job Information
Amgen Regulatory Operation Manager-Beijing in Beijing, China
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