Senior Gxp System And Process Specialist, Global Regulatory Affairs
Ferring Pharmaceuticals
Denmark
Veeva rim system expertise
Gxp systems and business processes
Regulatory document management
Drive business system operations and ensure optimal use of Veeva RIM systems supporting regulatory document management, submission management and information management
Job Summary
Drive business system operations and ensure optimal use of Veeva RIM systems supporting regulatory document management, submission management and information management.
Act as the key interface between Regulatory Affairs, IT and external vendors, translating business needs into system enhancements.
Work in a multicultural and interdisciplinary environment with colleagues and user community located throughout the global Ferring organisation.
Matching Summary
Drive business system operations and ensure optimal use of Veeva RIM systems supporting regulatory document management, submission management and information management.
Skills & Requirements
Must-have
Veeva RIM system expertise
GxP systems and business processes
Regulatory document management
Submission management
Information management
System inspection readiness
Nice-to-have
Analytical and problem-solving skills
Structured and proactive approach
Stakeholder management skills
Cross-functional and global environments
Key Requirements
Master’s degree in Life Sciences or IT/Science
Several years of experience in Regulatory Affairs/Operations
Understanding of regulatory end-to-end processes
Familiarity with global regulatory requirements
Hands-on experience with Veeva Vault RIM
Experience with system ownership/product ownership/application management