The Regulatory Affairs Operations role supports regional activities related to the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems
Job Summary
The Regulatory Affairs Operations role supports regional activities related to the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
This role partners with multiple internal stakeholders to ensure successful regional implementation of regulatory systems and continuous enhancement of capabilities and processes.
The position involves providing direct user support, facilitating training, leading change management initiatives, and collaborating across regions to align activities and share best practices.
Matching Summary
The Regulatory Affairs Operations role supports regional activities related to the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems.
Skills & Requirements
Must-have
Regulatory information systems support
Veeva platform experience
Change management expertise
Project management methodologies
Regulatory submissions content management
Cross-functional team leadership
Data quality improvement
Nice-to-have
Business process modeling
Communication strategy development
Digital strategy participation
Training material development
Automation opportunity identification
Fluent in English and regional language
Key Requirements
Bachelor’s degree in science, IT or Pharmacy
2-4 years regulatory affairs or operations experience
3 years regulatory information systems implementation/support
Experience with Veeva platform
Project management experience
Change management and training development experience