Sr. Specialist, System Process & Regulatory Innovation
Core
Execute and own delivery of assigned system, process, and data-related activities end-to-end for regulatory operations across the APAC region, ensuring compliance and data integrity.
Role type
Senior Specialist, System Process & Regulatory Innovation (Individual Contributor)
Builds
Operational execution of regulatory systems, processes, and digital initiatives for the Asia Pacific region
Domain
Pharmaceutical Regulatory Affairs / Regulatory Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Affairs, Regulatory Operations, System implementation, Testing and validation, User support activities, Data quality initiatives, Process improvement, System enhancements, Submission planning and execution, Regulatory information management
Preferred skills
Project management methodologies, Change management, Process re-engineering, Analytics and reporting tools, Training material development
Technologies
Cognos, PowerApps, ChatGPT
Responsibilities
Execute and own delivery of assigned system, process, and data-related activities end-to-end; Ensure timely execution, stakeholder alignment, and adherence to governance and compliance requirements; Provide end-user support and enablement across regulatory systems and processes; Drive data quality and continuous improvement activities; Support system implementation, enhancements, and change activities; Contribute to governance and strategy activities within defined scope
Seniority
Senior, hands-on IC
