Regulatory Intelligence & AI Enablement Lead – Remote – up to £500 per at Ventula Consulting Limited, The City, London, £500 per day

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

1. 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.

2. 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 cleint supports multi-functional HAQ workflows.

-Support the development of AI features like historical HAQ matching, citation generation, and prompt refinement.

3. 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.

4. 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.

5. 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.