Head of Regulatory Information Management Systems and Digitalisation

Job Description Summary

At Sandoz our Purpose is pioneering access for patients

Job Description

Regulatory Information Management Systems (RIMS) and Digitalisation requires a blend of regulatory domain expertise systems leadership digital transformation capability and a strong focus on automation and AIenabled process optimisation. They will be a key member of project teams responsible for system definition selection and implementation and take a lead role in evaluating and proposing ongoing process and system improvements aligned with developments based on industry best practice

This role ensures that RIMS platforms business processes automation solutions and emerging AI technologies are designed and operated to deliver highquality regulatory data efficient submission operations and seamless Health Authority interactions. The role drives the digital transformation of regulatory affairs enabling scalable compliant and futureready regulatory operations processes and ways of working to ensure positive reliable and repeatable outcomes. They will act as system owners responding to requests for solutions pertaining to but not limited to data gathering/reporting and aiding users in more complex system tasks or troubleshooting.

The role also requires the candidate to have complete oversight and responsibility for coordinating the training and support activities to all end users of systems for which RA are the business owners this includes ownership of all training materials including responsibility and oversight for the creation and maintenance to ensure training compliance for all end users.

Your responsibilities include but not limited to:

Leadership of RIMS Strategy and Delivery

• Own the global RIMS strategy ensuring the system supports endtoend 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.

Digitalisation and Automation of Regulatory Processes

• 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) lowcode workflows and intelligent document processing solutions.

Exploration and Deployment of AI Opportunities

• Lead the investigation and evaluation of AI technologies that can enhance regulatory processes including NLP machine learning generative AI and predictive analytics.

• Develop AIenabled 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.

CrossFunctional Collaboration

• Partner with Regulatory Affairs CMC Safety Quality Supply Chain and IT to ensure regulatory systems and data support crossfunctional needs. Direct involvement in STEP and AURORA initiatives leading the regulatory pathways required for success in these corporate projects with a primary focus on business process optimisation and efficiency gains for all regulatory processes including those that interface with larger more complex end to end processes that span multiple functions and stakeholders

• Represent regulatory digitalisation in enterpriselevel digital transformation initiatives and governance forums.

• Collaborate with affiliates and regional teams to ensure global adoption and consistency of processes and systems.

Team Leadership and Capability Building

• 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 datadriven decisionmaking.

What youll bring to the role:

Essential Requirements:

Working and thinking level

• Strategic global process mindset at an enterprise level

• Project and solution-oriented working and thinking focused on relationships and the achievement of ambitious goals

• Proven track record of implementing cross functional process changes and leadership experience of complex change management projects to successful outcomes

Education

• Minimum: Degree or equivalent work experience

• Fluent English required (oral and written)

• Expert knowledge of regulatory affairs with a deep understanding end to end regulatory processes

• Understanding of the current AI and Automation landscape and the future capabilities of such technologies to augment and improve operational efficiency and optimize regulatory and cross functional processes and data flows that are reliant and robust and well designed regulatory processes and data

Experience

• Experienced global regulatory operations professional with 15 years of regulatory 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

• Expert operating knowledge and understanding of the Veeva ecosystem and its associated cross functional data dependencies and data model including existing and forthcoming AI agents and Automation models and deep understanding of data and documentation dependencies across the Veeva vault platforms at a cross functional level (Quality PV Clinical Labelling)

• Full and detailed understanding of Veeva vault best practice and configuration design principles

• Deep understanding of RIMS platforms regulatory workflows and structured data requirements

• Strong knowledge of global regulatory data standards (IDMP xEVMPD PMS)

• Ability to develop and deliver training programmes for new regulatory platforms processes and best practices

• Capability to design 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

Youll receive:

United Kingdom : Competitive salary Annual bonus Pension scheme Health insurance 24 days annual leave Flexible working arrangements Employee recognition scheme learning and development opportunities.

Netherlands: We offer temporary employment for 1 year with probation period with flexible working learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.

Why Sandoz

Sandoz is the global leader in Biosimilar and Generic medicines a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost touching the lives of more than 1 billion people across 100 countries! While we are proud of our achievements we have an ambition to do more so that everyone can achieve the basic humanrightof good health.

With investments in new development capabilities production sites new acquisitions and partnerships wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost high-quality medicines sustainably.

Our momentum is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful careers where diversity of thought is welcomed and where personal growth is supported!

Join us help us make healthcare fairer and faster.

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.

#Sandoz

Skills Desired

Data Analysis Documentation Management Lifesciences People Management Process Improvement Regulatory Compliance

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1