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 in Ferring, supporting regulatory document management, submission management and information management
Job Summary
Drive business system operations and ensure optimal use of Veeva RIM systems in Ferring, 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.
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
Matching Summary
Drive business system operations and ensure optimal use of Veeva RIM systems in Ferring, 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 ownership
Product ownership
Application management
Nice-to-have
Analytical and problem-solving skills
Structured and proactive approach
Change and project management
Stakeholder management
Communication skills
Multicultural and interdisciplinary environment
Key Requirements
Master’s degree in Life Sciences or Information Technology/Science
Several years of experience in Regulatory Affairs or Regulatory Operations
Understanding of regulatory end-to-end processes
Familiarity with global regulatory requirements
Experience in or desire for working in cross-functional and global environments