Sr. Specialist, System Process & Regulatory Innovation
Merck & Co., Inc., Rahway, NJ, USA
Rahway, New Jersey, USA
Hybrid
Regulatory content and submission management
Regulatory information systems
Process digitization and automation
Support the regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities, acting as a primary contact for regional users on system usage and business processes
Job Summary
Support the regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities, acting as a primary contact for regional users on system usage and business processes.
Evaluate regional data, identify data quality and compliance issues, and develop/implement action plans, while contributing to regional and global projects that enable regulatory and business strategies.
Collaborate with various GRACS functions to deliver regional objectives, translate regional needs into actionable plans, and provide direct support for GRACS RIIM tools.
Matching Summary
Support the regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities, acting as a primary contact for regional users on system usage and business processes.
Skills & Requirements
Must-have
Regulatory content and submission management
Regulatory information systems
Process digitization and automation
Microsoft Power Platform
Gen AI
Data quality and compliance issues
Nice-to-have
Strong interest in regulatory technology
Process excellence
Lead and influence without authority
Collaboration and stakeholder engagement
Key Requirements
2-4 years experience in Regulatory Affairs/Operations/pharmaceutical manufacturing
At least 3 years implementing/supporting regulatory information systems
Bachelor's degree in science, IT, Pharmacy, or related discipline