Regulatory Intelligence & AI Enablement Lead – Remote – up to £500 per

Regulatory Intelligence & AI Enablement Lead – Remote – up to £500 per

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£500 Per day
Outside
Remote
The City, City of London (EC3), EC3V 9DU
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Artificial Intelligence Automation Data Science External Auditing Milestones (Project Management) Product Leadership Product Roadmaps Stakeholder Engagement Stakeholder Management User Experience Verification And Validation Workflows

Summary: The Regulatory Intelligence & AI Enablement Lead will leverage regulatory expertise and AI knowledge to enhance a GenAI-powered platform aimed at automating Health Authority responses. This role involves product ownership, stakeholder engagement, and ensuring compliance while driving the adoption of AI features. The individual will collaborate with various subject matter experts to ensure the platform meets regulatory standards and delivers measurable business value. The position is fully remote and offers a competitive daily rate.

Key Responsibilities:

  • Serve as the product owner for within the RA technology capability team, managing its lifecycle from design to adoption.
  • Define and maintain a product roadmap aligned with RA digitalization goals and the broader platform strategy.
  • Ensure the product delivers business benefits, simplifies the technology landscape, and supports future readiness.
  • Lead the business validation of AI-generated responses to HAQs, ensuring scientific and regulatory accuracy.
  • Collaborate with SMEs across disciplines (e.g., CMC, Nonclinical, Clinical, Safety) to ensure client supports multi-functional HAQ workflows.
  • Support the development of AI features like historical HAQ matching, citation generation, and prompt refinement.
  • Guide prompt engineering and model fine-tuning to reflect regulatory language, study codes, and structured content.
  • Partner with IT and data science teams to ensure system performance, integration with upstream/downstream tools, and adherence to compliance standards.
  • Raise and manage demand for new features or operational support from RA functions.
  • Represent client in digital governance boards and cross-functional leadership forums.
  • Act as a change lead to drive adoption, training, and communication across RA and partner functions.
  • Foster a digital mindset and AI literacy within the regulatory community.
  • Ensure complies with security and regulatory standards; support audits and inspections.
  • Oversee vendor performance and integration quality in collaboration with IT and external partnerships.

Key Skills:

  • Regulatory expertise in Health Authority processes.
  • Strong understanding of AI technologies and their application in regulatory affairs.
  • Experience in product ownership and strategy development.
  • Ability to collaborate with cross-functional teams and subject matter experts.
  • Strong communication and stakeholder engagement skills.
  • Knowledge of compliance standards and audit processes.
  • Experience in managing vendor relationships and performance oversight.

Salary (Rate): £500 per day

City: The City, City of London (EC3)

Country: United Kingdom

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: IT

Detailed Description From Employer:

Regulatory Intelligence & AI Enablement Lead – Remote – up to £500 per day

Overview

This role combines regulatory expertise, AI literacy, and product leadership to drive the success of the client — a GenAI-powered platform for Health Authority (HA) response automation. The individual will act as a business-facing product lead, ensuring that delivers measurable value to Regulatory Affairs (RA) and adjacent functions through harmonized, compliant, and user-centric solutions.

Key Responsibilities

  • Product Ownership & Strategy
    • Serve as the product owner for within the RA technology capability team, managing its lifecycle from design to adoption.
    • Define and maintain a product roadmap aligned with RA digitalization goals and the broader platform strategy.
    • Ensure the product delivers business benefits, simplifies the technology landscape, and supports future readiness.
  • HAQ Response Enablement
    • Lead the business validation of AI-generated responses to HAQs, ensuring scientific and regulatory accuracy.
    • Collaborate with SMEs across disciplines (e.g., CMC, Nonclinical, Clinical, Safety) to ensure client supports multi-functional HAQ workflows.
    • Support the development of AI features like historical HAQ matching, citation generation, and prompt refinement.
  • AI Integration & Technical Collaboration
    • Guide prompt engineering and model fine-tuning to reflect regulatory language, study codes, and structured content.
    • Partner with IT and data science teams to ensure system performance, integration with upstream/downstream tools, and adherence to compliance standards.
    • Raise and manage demand for new features or operational support from RA functions.
  • Stakeholder Engagement & Change Leadership
    • Represent client in digital governance boards and cross-functional leadership forums.
    • Act as a change lead to drive adoption, training, and communication across RA and partner functions.
    • Foster a digital mindset and AI literacy within the regulatory community.
  • Quality, Compliance & Vendor Oversight
    • Ensure complies with security and regulatory standards; support audits and inspections.
    • Oversee vendor performance and integration quality in collaboration with IT and external partnerships.

Performance Indicators

  • Timely and on-budget delivery of roadmap milestones.
  • Demonstrated adoption and measurable impact on HAQ response timelines and quality.
  • Improved user experience and reduced system complexity across RA.
  • No critical audit findings related to or its integrations.

This is a 3 month contract offering £400-£500 per day outside of IR35 fully remote.

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