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Director, Regulatory AI Business Partner

AstraZeneca · Cambridge Kendall SQ, MA

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RegulatoryFull-time$186k–$279kCompany career page

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Role summary

AstraZeneca seeks a Director to bridge AI innovation and regulatory affairs, serving as the senior business partner between clinical development AI teams and the enterprise regulatory function. The role involves translating regulatory priorities into AI opportunities, ensuring compliant and responsible AI implementation, and demonstrating measurable value across shared and function-specific solutions.

What they're looking for

  • Deep understanding of regulatory affairs functions, workflows, and submission standards
  • Experience translating business needs into AI/data science solutions
  • Demonstrated ability to build trust and credibility with senior cross-functional stakeholders
  • Familiarity with clinical data governance, data infrastructure, and audit-ready environments
  • Comfort navigating ambiguity with bias toward early value demonstration
  • Experience in responsible AI, compliance, and risk management frameworks

What you'll be doing

  • Serve as primary business partner between AI for Clinical Development and Regulatory function
  • Develop prioritized, sequenced AI opportunities aligned with Regulatory's digital roadmap
  • Identify and flag regulatory compliance requirements for AI solutions under development
  • Define success metrics, build business cases, and track adoption and value realization
  • Interface with IT, data, and technical teams to ensure feasibility and audit-ready implementation

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