Associate Director, Non-clinical Data And Documents

AstraZeneca

Hybrid (minimum of three days in-office per week)
Veeva vault rim experience
Submission ready standard governance
Non-clinical data document management
The Associate Director, Non-Clinical Data and Documents role at AstraZeneca involves leading a team responsible for regulatory submissions, focusing on data document management and archiving. The position emphasizes operational excellence, people management, and compliance with health authority standards to ensure submission readiness. ###

Job Summary

  • This role leads a specialist team to ensure high-quality regulatory submissions meet health authority requirements and the Submission Ready Standard.
  • The position requires overseeing document management activities, including review, QC, approval, and archival while maintaining robust version control and audit readiness.
  • Candidates must drive excellence in document formatting, validation error management, and provide oversight of Veeva Vault RIM publishing tools for eCTD submissions.

Matching Summary

Match Score: 85

The Associate Director, Non-Clinical Data and Documents role at AstraZeneca involves leading a team responsible for regulatory submissions, focusing on data document management and archiving. The position emphasizes operational excellence, people management, and compliance with health authority standards to ensure submission readiness. ###

Skills & Requirements

Must-have

  • Veeva Vault RIM experience
  • Submission Ready Standard governance
  • Non-clinical data document management
  • eCTD structure and technical compliance
  • Team leadership in regulatory operations
  • GxP environment compliance

Nice-to-have

  • Root cause analysis for validation errors
  • Archiving physical raw data strategy
  • Advanced Word/PDF formatting skills
  • Stakeholder relationship building
  • Continuous improvement culture

Key Requirements

  • Master's degree in life sciences or related field
  • Minimum 8 years in regulatory operations or document management
  • At least 3 years of people leadership experience
  • PhD or equivalent qualification preferred
  • Experience with GxP environments and inspection support

Work Rights

Not specified

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