Specialist- Regulatory Affairs Process Digitalization & AI

Job description

Partner with Regulatory Affairs stakeholders to identify opportunities for AI-enabled process improvements across regulatory planning, submission preparation, document management, lifecycle management, and regulatory intelligence. Design, develop, and deploy production-ready AI applications, AI agents, and knowledge assistants that automate Regulatory Affairs workflows and improve operational efficiency. Develop intelligent document processing solutions for regulatory documentation, including extraction, classification, summarization, comparison, and validation of structured and unstructured documents such as technical files, submission dossiers, standards, guidance documents, and health authority correspondence. Build and optimize Retrieval-Augmented Generation (RAG) solutions that enable secure and accurate retrieval of regulatory knowledge from internal repositories and enterprise systems. Apply prompt engineering, output validation, retrieval benchmarking, and AI quality assurance practices to ensure reliable, explainable, and compliant AI solutions. Integrate AI solutions with enterprise platforms including Azure OpenAI, Microsoft Copilot Studio, Microsoft Foundry, AWS Bedrock, Power BI, SharePoint, and Regulatory Affairs systems. Develop or/and maintain workflow automation and KPI dashboards to improve visibility of Regulatory Affairs performance, submission status, process efficiency, and operational metrics. Collaborate with cross-functional teams to translate Regulatory Affairs business requirements into scalable AI-enabled solutions while ensuring compliance with data governance, security, and responsible AI principles. Continuously evaluate emerging AI technologies and recommend innovative solutions to support the digital transformation of Regulatory Affairs.