Gxp and computer systems validation (csv) expertise
Software development life cycle (sdlc) leadership
This role is responsible for establishing and executing the central regulatory affairs strategy for digital tools across all business units and regions
Job Summary
This role is responsible for establishing and executing the central regulatory affairs strategy for digital tools across all business units and regions.
The position requires managing global RA digital platforms including submission management, advertising and promotion, and regulatory information systems.
Candidates must have a minimum of 15 years of experience working with IT to launch and maintain RA systems following GxP and CSV standards.
Matching Summary
This role is responsible for establishing and executing the central regulatory affairs strategy for digital tools across all business units and regions.
Salary
Base: $230,300.00 - $368,500.00 USD Annual; Bonus/Equity: Annual Bonus Potential and Discretionary LTI Bonus Potential; Benefits: Comprehensive health, wellness, retirement, and paid time off packages
Skills & Requirements
Must-have
15+ years IT experience with RA systems
GxP and Computer Systems Validation (CSV) expertise
Software Development Life Cycle (SDLC) leadership
Global Regulatory Affairs strategy development
Budget and resource planning for digital initiatives