Associate Graas Operations

Amgen Australia Pty Ltd

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Maintain regulatory document management systems
Manage fda 1572 forms
Update rsdims and analytics tools
** Amgen Australia Pty Ltd is seeking an Associate in their Global Regulatory Affairs Execution Team, focusing on data management and regulatory compliance. The role involves monitoring data quality, managing regulatory submissions, and collaborating with internal and external partners to ensure efficient operations. **

Job Summary

  • The role ensures the smooth compliant flow of information between functional areas, local offices, and regulatory authorities.
  • Key responsibilities include maintaining regulatory archives, managing Protocol Amendment New Investigator submissions, and overseeing document storage.
  • The position requires collaboration with external partners, CROs, and internal teams to support submission and approval dates.

Matching Summary

Match Score: 75

** Amgen Australia Pty Ltd is seeking an Associate in their Global Regulatory Affairs Execution Team, focusing on data management and regulatory compliance. The role involves monitoring data quality, managing regulatory submissions, and collaborating with internal and external partners to ensure efficient operations. **

Skills & Requirements

Must-have

  • Maintain regulatory document management systems
  • Manage FDA 1572 forms
  • Update RSDIMS and Analytics tools
  • Ensure compliance with SOPs and regulations
  • Collaborate with internal and external partners

Nice-to-have

  • Experience in operational regulatory affairs role
  • Familiarity with Global Clinical Trial Applications
  • Basic understanding of Veeva Vault system
  • Strong critical thinking and time management skills
  • Ability to work in demanding situations with tact

Key Requirements

  • Bachelor's degree OR Associate's degree with 4 years experience
  • High school diploma with 6 years directly related experience
  • Experience in an operationally focused role within Regulatory Affairs preferred

Work Rights

Not specified

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