Specialist- Regulatory Affairs Process Digitalization & AI
Core
Design, develop, and deploy AI applications and agents to automate Regulatory Affairs workflows, manage document processing, and enable secure knowledge retrieval.
Role type
Senior IC machine-learning engineer (regulatory affairs)
Builds
Production-ready AI applications, AI agents, knowledge assistants, intelligent document processing solutions, and RAG systems
Domain
Healthcare/Pharmaceuticals + AI/ML
Deliverable
production ML models | product features
Required skills
AI application development, RAG solution architecture, intelligent document processing, prompt engineering, AI quality assurance, enterprise platform integration, workflow automation, KPI dashboard development
Preferred skills
Azure OpenAI, Microsoft Copilot Studio, AWS Bedrock, Power BI, SharePoint
Technologies
Azure OpenAI, Microsoft Copilot Studio, Microsoft Foundry, AWS Bedrock, Power BI, SharePoint
Responsibilities
Partner with stakeholders to identify AI opportunities for regulatory planning and submission preparation; Develop intelligent document processing for extraction, classification, and validation of regulatory dossiers; Build and optimize RAG solutions for regulatory knowledge retrieval; Integrate AI solutions with enterprise platforms; Develop workflow automation and KPI dashboards; Collaborate on translating business requirements into scalable AI solutions; Evaluate emerging AI technologies for digital transformation.
