Senior Specialist managing regional regulatory projects and supporting compliance systems for healthcare company. Implementing digital strategy initiatives and collaborating with stakeholders through process improvement.
Responsibilities
Support regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities
Act as primary contact (or secondary support) for regional users on system usage, business processes, and process improvement initiatives; provide user training as needed
Understand underlying business processes; work with BPOs to adapt procedures to regional and local regulatory requirements
Evaluate regional data, identify data quality and compliance issues, and develop/implement action plans
Ensure timely regional input and delivery of tasks for global projects
Contribute to regional and global projects that enable regulatory and business strategies
Collaborate with RAI, iCMC, GRACS O.P.S, PV, and other GRACS functions to deliver regional objectives
Translate regional needs and external changes into actionable plans aligned with the GRACS Digital Strategy; support communications and change management activities
Provide direct support for GRACS RIIM tools
Organize/participate in regional communication forums to share updates on processes and system changes
Support development and delivery of global/regional regulatory training and refresher sessions
Requirements
Education: Bachelor’s degree in a science, information technology, Pharmacy, or related discipline required
Advanced degree (engineering or scientific discipline, MBA) preferred
Required Experience & Skills: Around 2–4 years’ experience in Regulatory Affairs, Regulatory Operations, and/or pharmaceutical manufacturing
At least 3 years’ experience implementing and/or supporting regulatory information systems
Demonstrated ability to lead and influence without direct authority
Strong organizational awareness
Proven problem-solving skills; experience analyzing information and implementing actions to improve data quality, processes, or systems
Experience in project management methodologies, change management, process re-engineering, analytics and reporting (e.g., Cognos, PowerApps, ChatGPT)
Strong critical thinking and collaboration skills
Fluent in English; fluency in a relevant regional language is an advantage.
Benefits
Flexible Work Arrangements: Hybrid
Professional Development opportunities
Job title
Senior Specialist, System Process & Regulatory Innovation
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