Provides key support to the Nurix Regulatory Affairs department with responsibility for coordination, review, assembly and archival of regulatory submissions
Job Summary
Provides key support to the Nurix Regulatory Affairs department with responsibility for coordination, review, assembly and archival of regulatory submissions.
Manages and supports Veeva RIMS processes, including authoring and review workflows, and maintains archival copies of health authority submissions.
Maintains current knowledge of applicable US and global regulations and guidance, and contributes to SOPs and training materials.
Matching Summary
Provides key support to the Nurix Regulatory Affairs department with responsibility for coordination, review, assembly and archival of regulatory submissions.
Salary
Base: 140K - 160K; Bonus/Equity: plus bonus & equity; Benefits: Not specified
Skills & Requirements
Must-have
Veeva RIMS SCP
regulatory submissions
health authority documentation
eCTD
ICH guidelines
Nice-to-have
drug development process
cross-functional teams
solutions and results-oriented
Key Requirements
4-5 years' experience in Regulatory Affairs or Regulatory Operations
Bachelor's Degree in Life Sciences or relevant field