Job Title

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. TPBN1_UKTJ