Pharmaceutical Data and AI Regulatory Intelligence expert. Barcelona based.
Advise on and support AZ Regulatory intelligence tool implementation, e.g. scope, mapping of requirements, approach
Define and document AZ Enterprise Data and AI Regulatory Intelligence Framework to include:
Op Model for Regulatory Intelligence capability services and consumer groups
Clear roles & accountabilities
Regulatory change impact risk scoring matrix
Align functional regulatory change impact template and map functional requirements to a single enterprise impact regulatory change assessment template for Regulatory Intelligence
Establish regular framework feedback cadence from stakeholders to Regulatory Intelligence
Review horizon scanning processes and make recommendations for centralised process.
Regulatory interpretation and guidance on mandatory requirements
Adherence to compliance monitoring and enforcement with regards to regulatory change processes and procedures
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