Regulatory Data & Systems Manager

Amgen UK

5+ years business analyst experience
Veeva vault knowledge required
Gxp requirements and systems validation
The Regulatory Data & Systems Manager will facilitate system administration tasks while interpreting requirements based on industry best practices and Amgen regulatory processes

Job Summary

  • The Regulatory Data & Systems Manager will facilitate system administration tasks while interpreting requirements based on industry best practices and Amgen regulatory processes.
  • This role involves managing complex systems to ensure compliance with regulatory regulations and facilitating effective communication between various departments involved in the submission process.
  • The ideal candidate must have a strong background in system analysis, regulatory affairs, and project management with proven Veeva Vault knowledge.

Matching Summary

The Regulatory Data & Systems Manager will facilitate system administration tasks while interpreting requirements based on industry best practices and Amgen regulatory processes.

Skills & Requirements

Must-have

  • 5+ years business analyst experience
  • Veeva Vault knowledge required
  • GxP requirements and systems validation
  • Agile methodologies Scrum or Kanban
  • Regulatory affairs background

Nice-to-have

  • Strong interpersonal and teamwork skills
  • Experience in matrix environment
  • IDMP regulatory data standards familiarity
  • Global regulatory processes knowledge

Key Requirements

  • Bachelor's degree and 8 years related experience
  • 5+ years as a business analyst
  • Proven Veeva Vault knowledge
  • Familiarity with GxP requirements
  • Life Sciences or Biotech industry experience

Work Rights

Not specified

Tailored Resume

Cover Letter