Head of Regulatory Information Management Systems and Digitalisation in Cambridge

Job Description Summary

At Sandoz, our Purpose is pioneering access for patients.

The Regulatory Information Management Systems (RIMS) and Digitalisation role blends regulatory domain expertise, systems leadership, digital transformation capability, and a strong focus on automation and AI‑enabled process optimisation.

The successful candidate will be a key member of project teams responsible for system definition, selection, implementation, and continual improvement of RIMS platforms, business processes, automation solutions, and emerging AI technologies to deliver high‑quality regulatory data and efficient submission operations.

Responsibilities

• Own the global RIMS strategy and ensure the system supports end‑to‑end regulatory processes, data standards, and lifecycle management.
• Lead the design, implementation, and optimisation of RIMS capabilities, including integrations with document management, safety, quality, and manufacturing systems.
• Define and maintain regulatory business processes that align with system capabilities and global regulatory requirements.
• Oversee system upgrades, enhancements, and user experience improvements to ensure stability, usability, and compliance.
• Develop and execute a digitalisation roadmap that modernises regulatory operations through workflow automation, structured data, and intelligent process design.
• Identify opportunities to automate manual regulatory tasks, such as metadata capture, submission tracking, Health Authority correspondence management, and lifecycle updates.
• Partner with IT and automation teams to implement robotic process automation (RPA), low‑code workflows, and intelligent document processing solutions.
• Lead the investigation and evaluation of AI technologies that can enhance regulatory processes, including NLP, machine learning, generative AI, and predictive analytics.
• Develop AI‑enabled use cases such as automated document classification, impact assessments, regulatory intelligence scanning, and predictive submission planning.
• Ensure AI solutions are implemented responsibly, with appropriate governance, validation, and compliance controls.
• Collaborate with Regulatory Affairs, CMC, Safety, Quality, Supply Chain, and IT to ensure regulatory systems and data support cross‑functional needs.
• Lead regulatory pathways for enterprise projects such as STEP and AURORA, focusing on business process optimisation and efficiency gains.
• Represent regulatory digitalisation in enterprise‑level digital transformation initiatives and governance forums.
• Collaborate with affiliates and regional teams to ensure global adoption and consistency of processes and systems.
• Lead a global team responsible for RIMS administration, regulatory digitalisation, automation, and data governance.
• Build capabilities in regulatory informatics, automation technologies, AI literacy, and digital process design.
• Foster a culture of innovation, continuous improvement, and data‑driven decision‑making.

Essential Requirements

Working and thinking at a strategic, global process mindset at an enterprise level; project and solution‑oriented with a focus on relationships and ambitious goal achievement; proven track record of implementing cross‑functional process changes and leading complex change management projects to successful outcomes.

Education Minimum

Degree or equivalent work experience; fluent English (oral and written).

Experience

• 15+ years of regulatory operations experience in roles of increasing accountability and complexity, ideally in the generic field.
• Expert understanding of global and regional regulatory data models and structured data guidelines.
• Deep understanding of the Veeva ecosystem, its cross‑functional data dependencies, and data model including AI agents and automation models.
• Comprehensive knowledge of Veeva vault best practice and configuration design principles.
• Strong knowledge of global regulatory data standards (IDMP, x EVMPD, PMS).
• Capability to develop and deliver training programmes for new regulatory platforms, processes, and best practices.
• Experience designing digital roadmaps to modernise regulatory operations.
• Experience with automation technologies (RPA, workflow tools, intelligent document processing).
• Understanding of AI capabilities in regulated environments and ability to translate needs into AI‑enabled use cases.
• Expertise in master data management, metadata structures, data lineage, and ensuring accuracy, compliance, and audit readiness.
• Ability to align stakeholders on system and process changes with strong communication and change‑management skills.
• Ability to anticipate regulatory and technology trends, diagnose issues, and implement sustainable solutions.
• Experience leading global teams, building capabilities, and driving innovation and continuous improvement.

Skills Desired

• Data Analysis
• Documentation Management
• Lifesciences
• People Management
• Process Improvement
• Regulatory Compliance
• You’ll Receive
• United

Kingdom: Competitive salary, annual bonus, pension scheme, health insurance, 24 days annual leave, flexible working arrangements, employee recognition scheme, and learning and development opportunities.

• Netherlands: Temporary employment for 1 year with a probation period and flexible working; learning and development opportunities; indefinite employment contract based on performance after the first year.
• Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#J-18808-Ljbffr