Global Head of Technology

The Stakeholder Success Lead - Global Head of Technology RA Solutions is focused on ensuring that Regulatory Affairs stakeholders successfully achieve their goals using the technology systems provided. This role involves closely working with Regulatory Affairs stakeholders to understand their evolving needs, challenges, opportunities, and priorities, and ensuring that their automation and information needs are met by collaborating with other members of their functional unit and/or other functional units. Stakeholder Success Leads play a crucial role in representing the face of Technology to the stakeholder community they serve.

• Stakeholder Engagement
  • Facilitate effective dialogues to identify business issues, challenges, and opportunities that can be addressed through technology.
  • Align Regulatory Affairs technology strategy with business directives and needs.
  • Manage Technology priorities for the Regulatory Affairs business area.
  • Develop and maintain relationships with key Regulatory Affairs leaders to ensure alignment of Technology services with Regulatory Affairs objectives.
  • Conduct regular meetings with Regulatory Affairs stakeholders to gather requirements and feedback.
• Project Management
  • Ensure the capture of functional requirements and design specifications for Regulatory Affairs technology solutions.
  • Coordinate technology delivery of the Regulatory Affairs IT portfolio and priorities, ensuring projects are on schedule and outcomes are of high quality.
  • Collaborate with Technology teams to develop and implement solutions that address Regulatory Affairs stakeholder needs.
  • Monitor and report on the progress of Regulatory Affairs Technology projects and initiatives.
  • Implement risk management strategies to ensure project success.
• Budget and Resource Optimization
  • Meet operational and project budgets.
  • Effectively lead and manage the Regulatory Affairs Stakeholder Success team.
  • Identify, manage, and improve vendor relationships.
  • Optimize resource allocation to ensure maximum efficiency and cost-effectiveness.
  • Develop and manage financial forecasts and budgets for technology projects.
• Innovation and Improvement
  • Identify opportunities for technological innovation within Regulatory Affairs.
  • Continually update personal knowledge of industry trends and developments to enhance solutions provided to Regulatory Affairs.
  • Maintain a detailed understanding of how Regulatory Affairs processes are operationalized within technology tools.
  • Encourage and support the adoption of new technologies and processes.
  • Lead pilot programs for new technology solutions and assess their effectiveness.
• Communication and Coordination
  • Drive the adoption of the Technology Organization s standards and solutions.
  • Ensure smooth execution and maintain clear lines of communication between cross-functional Technology teams and Regulatory Affairs.
  • Coordinate with other functional units to ensure alignment and integration of technology solutions.
  • Develop and maintain communication channels to provide regular updates and feedback to stakeholders.

• Stakeholder Engagement
  • Ensure high levels of Regulatory Affairs stakeholder satisfaction through proactive engagement and effective solution delivery.
  • Maintain ongoing communication with stakeholders to ensure their needs are continuously met.
  • Ensure stakeholder feedback is effectively communicated to the Technology team for continuous improvement.
• Project Management
  • Oversee the delivery of Regulatory Affairs technology projects, ensuring they align with stakeholder needs and organizational standards.
  • Ensure project milestones are met and deliverables are achieved within budget and time constraints.
  • Provide regular project status updates to stakeholders and management.
• Budget and Resource Optimization
  • Ensure all technology initiatives are completed within the allocated budget.
  • Maintain strong vendor relationships to secure favorable terms and high-quality services.
  • Lead the Regulatory Affairs Stakeholder Success team in achieving financial and operational goals.
• Innovation and Improvement
  • Champion innovation within the Technology department by leveraging industry insights and Regulatory Affairs stakeholder feedback.
  • Ensure the Regulatory Affairs is at the forefront of technological advancements.
  • Drive continuous improvement initiatives to enhance service delivery and operational efficiency.
• Communication and Coordination
  • Maintain effective communication channels between Technology teams and Regulatory Affairs to ensure alignment and smooth service delivery.
  • Ensure that all stakeholders are informed and engaged throughout the project lifecycle.
  • Facilitate effective collaboration and information sharing among team members.

• Stakeholder Satisfaction: Measured through surveys and feedback mechanisms.
• Project Management: Timeliness, budget adherence, and quality of Technology projects delivered.
• Business Alignment: Degree to which Technology solutions meet the strategic needs of the business.
• Innovation & Improvement: Tangible benefits realized from new technologies and processes implemented.

• Bachelors degree in a relevant field (e.g., Computer Science, Business Administration).
• Master s degree or advanced certification in Business Management, Technology Management, or related disciplines is preferred.

• 10-15 years industry experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area.
• Proven track record in project management and stakeholder satisfaction (ideally related to Regulatory Affairs business area).
• Tenure in a management role overseeing complex projects.
• Proven track record of developing and implementing Regulatory Affairs technology strategies.
• Demonstrated ability to lead and mentor a dispersed technology team.
• Experience in regulatory and compliance environments, understanding the implications for technology solutions and data management in global markets.
• History of successful stakeholder engagement and relationship management

• Expert knowledge of Regulatory Affairs business processes and complexities
• Strong experience implementing and managing IT technologies supporting key business capabilities, incl. Submission / Document Management, Regulatory Information Management, Labelling, etc.
• A proven track record of implementing digital solutions to enhance regulatory business processes and experience in leading innovative projects that leverage AI, machine learning, and / or other advanced technologies to improve operational efficiency
• Excellent communication & presentation skills
• Networking with key business and IT stakeholders and ability to present to senior stakeholder groups.
• Strong teamwork and interpersonal skills at team and management levels, with the ability to establish and maintain a high level of trust and confidence.
• Excellent negotiation skills including vendor management experience.
• Excellent internal and/or external influencing skills to achieve the program objectives.
• Analytical, process-oriented with a keen interest to drive continuous improvements.
• Self-starter with ability to work with minimal supervision in a highly matrixed and multi-cultural environment, taking full ownership of deliverables.
• Acting as a role model for all people within the organization.
• Strong can-do attitude and results-focused, with capability to think strategically.

• Fluent English required (oral and written)

Business Acumen, Business Requirement Technical Analysis, Customer Requirements, Financial Modeling Information Technology Consulting, Stakeholder Management, Strategic Leadership, Strategic Planning, Talent Development, Waterfall Model