Executive Director – Regulatory Technology And Operational Excellence

Advances in digitalization, data and analytics are offering unprecedented opportunities for organization to reap unexploited business values. The digital transformation market size is predicted to grow from USD 521.5 billion in 2021 to USD 1247.5 billion by 2026. Digital in R&D is a 2025 critical strategic area of focus and the overall AstraZeneca strategy is geared to leap frog using digital as a platform.

Within Oncology Regulatory Science Strategy and Excellence (ORSSE) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Executive Director – Regulatory Technology and Operational Excellence has the responsibility to define, lead, co-create and implement the Regulatory Technology and Operational Excellence strategy within the scope of “Future of our Work” and the R&D Transformation. This strategy addresses the present and future needs of several areas:

• Enterprise Regulatory Vault (ERV) and Regulatory Information Management (RIM)
• The digital/data strategy for Regulatory Affairs
• The evolution of Submission Excellence and the implementation of Next Generation Submissions (NGS)
• The efficiency of shared cross project support, with close to 200 people in this organization working across all regulatory enterprise therapeutic areas (TAs)
• Processes, compliance & policy

The Head of Operational Excellence is a shared function and reports to the SVP Oncology Regulatory Science, Strategy and Excellence (ORSSE). The position is a member of the Regulatory Management Board (RMB) and participates in cross-enterprise regulatory governance activities and projects. The continuous revalidation and dynamic steering of fit-for-purpose enterprise-wide operational regulatory strategic roadmap should place AZ regulatory as a global innovative leader.

• Be a recognized inspiring leader in the digital ecosystem, proactively engaged with leaders outside the Pharma industry.
• Handle external engagement with potential partners and industry-driven platforms in the field of digital and regulatory IT.
• Grow and maintain internal and external collaborations.
• Identify data sources for regulatory specific information (drug labels, approval summaries, FDA/EMA/HA workshop presentations)
• Build an organization with new capabilities around the global regulatory operations strategy, digital innovation, regulatory data science and analytics, compliance & processes.
• The position develops and presents strategic plans to RMB governance for endorsement and implementation, provides regular reports to the RMB on the implementation of the overall strategy as well as critical information that needs to be brought to the attention of the TAs. As such the position is accountable to build productive interactions with the Regulatory TA Heads and other collaborators such as Clinical, Clinical Operations, Biometrics, Early Development, CMC and Marketing Companies.
• Maintain scientific and technical knowledge in the organization to enable development of groundbreaking opportunities to AZ.
• Drive innovative strategy for new technologies pertaining to regulatory informatics
• Coach, mentor, develop and lead senior leaders and identify skill development opportunities for direct reports, together with appropriate succession planning.
• Develop a coordinated and practical global regulatory digital strategy to support AZ portfolio, in a highly collaborative manner by co-creating digital solutions cross-functionally within AZ, i.e., looking at the technology landscape in Regulatory Affairs following NGS and implementing an innovative Regulatory Information Management System (ERV/RIM) that enables a “well-oiled system” allowing the cross-functional execution of AZ submissions in line with AZ objectives to reach a 6-week timeline between database lock and submission date by 2026.
• Handle budget and efficiency targets/metrics
• Use Storytelling as a digital tool to convince collaborators to adopt new culture and ways of working
• Attend and present at regulatory digital and technology conferences where experts and authorities express their perspectives on new technologies and develop AZ regulatory strategic plans accordingly.
• Ensure data quality by implementing data governance and industry standard quality processes and tools.
• Proactively understand the imperatives of the organization and act accordingly with the sense of urgency and innovative thinking
• The Head has knowledge of the application of Artificial Intelligence, Machine Learning, Deep Learning, Natural Language Processing, Knowledge Graphs, Quantum computing, Data Lakes & Cloud computing in the area of regulatory operations to articulate insights and opportunities to RMB leaders.

Minimum Qualifications:

• Experience in leading large-scale business/digital transformation & organizational change programmes using agile methodologies in a multi-national environment
• Biopharmaceutical industry experience with proven ability to leverage documents, data and analytics for insight-oriented decision making and for submissions.
• Effective Project/Portfolio and resource leadership skills, networking with broad range of customers and team members
• At least 10 years of validated experience and a master’s degree in Life Sciences, Pharmacy, or Medicine or another relevant business subject area
• Significant experience in a regulatory, clinical development & technology function in pharma, biotech or national health authorities

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

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