The Laboratory Animal Management Association is seeking a Regulatory Affairs - System Process & Innovation professional to support the implementation of Global Regulatory Affairs Digital Strategy projects. This role requires experience in regulatory affairs, particularly with the Veeva platform, and involves collaboration with various stakeholders to enhance regulatory systems and processes
Job Summary
Support regional activities for Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems, including content management, submission planning, and information management.
Partner with Innovation & Information Management and key stakeholders to ensure successful regional implementation of GRACS Regulatory systems and support continuous enhancements.
Evaluate regional data, create action plans for data quality issues, and represent regional needs in global project activities and change control boards.
Matching Summary
Match Score: 85
The Laboratory Animal Management Association is seeking a Regulatory Affairs - System Process & Innovation professional to support the implementation of Global Regulatory Affairs Digital Strategy projects. This role requires experience in regulatory affairs, particularly with the Veeva platform, and involves collaboration with various stakeholders to enhance regulatory systems and processes.
Skills & Requirements
Must-have
GRACS Digital Strategy projects
regulatory submissions content management
submission planning and execution
health registration systems
regulatory information management systems
continuous enhancements of capabilities
regional needs for system and process changes
system usage and existing process support
data quality issues evaluation
change management initiatives
cross-functional team leadership
Veeva platform experience
Nice-to-have
automation-based solutions exploration
global regulatory training development
best practices sharing
regional business and regulatory strategy support
Key Requirements
Bachelor's degree in science, IT, or Pharmacy
2-4 years experience in Regulatory Affairs or Operations
3+ years experience implementing/supporting regulatory information systems
Experience in project management methodologies
Experience with change management and training development