The Regulatory Data & Systems Manager will facilitate system administration tasks and interpret requirements based on industry best practices and Amgen regulatory processes
Job Summary
The Regulatory Data & Systems Manager will facilitate system administration tasks and interpret requirements based on industry best practices and Amgen regulatory processes.
This role involves managing complex systems to ensure compliance with regulatory regulations while facilitating effective communication between various departments involved in the submission process.
The ideal candidate must possess 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 and interpret 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 including Scrum or Kanban
Strong regulatory affairs background
Nice-to-have
Life Sciences industry experience preferred
IDMP regulatory data standards familiarity
Global regulatory processes knowledge
Excellent stakeholder communication skills
Ability to work in matrix environment
Key Requirements
Bachelor's degree and 8 years directly related experience
Associate's degree and 8 years directly related experience
High school diploma/GED and 8 years directly related experience
5+ years administering large scale enterprise systems