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Regulatory Operation Manager-Beijing

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary
Focus primarily on the filing and submission of CTNs, MAAs, variations, and other regulatory documents while optimizing processes to ensure efficient delivery, high quality, and compliance.

Key Activities

Filing and Submission:

  • Independently lead the submission of CTNs, MAAs, Variations, Renewals, Annual Reports, and RtQs in partnership with the TA/CMC team.
  • Manage submission dossier preparation with cross-functional teams (including translation/proofreading), and handle application submission and archiving of filings/approval files.
  • Analyze gaps and needs for China RA in early-phase submissions and generate standardized document requirements.
  • Control the filing strategy to facilitate simultaneous submissions.

Labeling Management:

  • Build and optimize the China labeling lifecycle management process from label creation to maintenance, ensuring compliance with China regulatory requirements and Amgen SOPs.
  • Localize labeling processes to meet quick turnaround times during Health Authority (HA) review in China.
  • Provide regulatory insight and operational expertise to cross-functional, regional, and global teams.
  • Manage post-approval label variations and ensure compliance with all regulatory requirements.
  • Familiar with labeling systems (similar to E2E system like LEXA) to facilitate label creation and maintenance tracking in China.

Project Management:

  • Expert in regulatory-related systems such as RIM, LEXA, GRIP, RA China SharePoint.
  • Organize internal project team meetings, track project progress, escalate flagged issues, record alignment in meeting minutes, and follow up on action items.
  • Maintain and update the regulatory dashboard to reflect project progress and achievements.
  • Collaborate with cross-functional, global, and regional teams to manage and implement enhanced regulatory quality processes to ensure compliance with China regulations and Amgen’s policies, procedures, and SOPs.

Other Activities:

  • Perform other activities as assigned by the line manager to support the China regulatory team.

Knowledge and Skills

  • Bachelor’s degree or above.
  • 4-6 years of industry experience with document submission.
  • Knowledge of local regulatory regulations.
  • Strong communication skills in both English and Chinese, both verbal and written.
  • Team player with the ability to collaborate effectively.
  • Proficient in Microsoft Outlook, Microsoft Teams, Miro, Word, Excel, PowerPoint, and Project.