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Amgen China RA Operation Team Lead in Beijing, China

Job Summary

  • Build China early phase submission management process to meet Chinese regulation requirements and align with Amgen global process and standard

  • Lead meeting request, CTN submissions, RTQ for early phase projects to ensure timely and quality submissions and speedy responses to the Health Authority in China

Key Activities

  • Lead early phase submission in partnership with TA team to establish RA submission strategy and model in China for the speed and purpose of fast land for Oncology / General medicine Early phase Pipeline. Analyze the gaps and needs for China RA in early phase submission, together with global and local team to build up China speedy and quality submission for early phase.

  • Establish process to be fully integrated into global process as architype country. Continuously optimize local submission management process from late phase model to meet Chinese regulation requirements and global Amgen standard.

  • Accumulate early phase submission and process experiences and provide operational expertise to project teams to ensure the timely, quality preparation and execution of paper and electronic submission to Health Authority starting from early phase projects to ensure future simultaneous global submission.

  • Being strategic partner with all cross functions / global / region proactively manage and drive changes and implementation of enhanced regulatory quality processes to ensure China Regulatory being compliant with regulations, Amgen’s global and local policy, procedures, SOPs

  • Drive and work with RA associates to identify process improvement areas, develop and update local working process particular for early phase projects

  • Proactively manage and implement new regulatory initiatives and guidelines and administrative procedure related to early phase

  • Collaborate with global, if China RA-related compliance trends identified.

  • Responsible for managing the archiving dossiers, certificate, approval letters and labeling for early phase To provide expertise support on RA database and other related system. (e.g. RIM, LEXA, GRIP, RA China SharePoint) related to early phase needs Aim for simultaneous global development for early phase submission

Knowledge and Skills

  • Communication skills in Chinese and English

  • Team player

  • People management

Education & Experience (Basic)

Over total 10 years’ experience for regulatory area

Education & Experience (Preferred)

Master degree