Regulatory Intelligence & AI Enablement Lead Remote up to £500 per
Regulatory Intelligence & AI Enablement Lead Remote up to £500 per day If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
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. xehkeey
Remote working/work at home options are available for this role.
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. xehkeey
Remote working/work at home options are available for this role.