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Lead the strategy and delivery of process excellence and learning for the International Regulatory organization to improve global regulatory delivery. Establish governance for operating models, manage the learning curriculum, and integrate digital tools to enhance organizational performance.
Requires over 10 years of experience in pharmaceutical regulatory affairs and the drug development life cycle. A university degree in science or a related discipline is required, along with proven leadership and global project management experience.
Are you ready to build a world-class regulatory capability engine that moves at pace? Can you turn complex change into simple, scalable ways of working that elevate performance across regions and roles? In this role, you will shape how our International Regulatory organisation learns, adapts and executes—directly enabling faster, higher-quality regulatory delivery that helps bring medicines to patients sooner. You will set the strategy and lead the delivery of process excellence and learning for a global community working across multiple regions and therapeutic areas. With the mandate to keep our operating model current and fit for purpose, you will translate evolving ways of working into clear procedures, role-based guidance and practical enablement that drives measurable outcomes. Backed by leaders who empower decisive action, you will partner across functions to embed new digital tools, ensure controlled and compliant change, and build a sustainable, role-based learning curriculum. Your work will convert evidence and insight into adoption and performance at scale, improving how teams collaborate and deliver across countries and time zones.
Accountabilities:
Strategy, Governance and Operating Model: Establish and run the governance for process and learning within International Regulatory, aligning priorities, resources, decisions and reporting to business needs and measurable outcomes.
Procedure Impact Assessment and Change Control: Lead a structured approach with SMEs, process owners, regional stakeholders, Quality/Compliance and tool owners to assess organisational, role and workflow changes; prioritise and govern controlled updates; and drive clear communication and traceability.
Process–Digital Tool Integration and Enablement: Define how changes in tools trigger procedural updates and user enablement; deliver targeted training and communications; identify impacted users; and monitor adoption and effectiveness to improve outcomes.
Curriculum Leadership and Capability Building: Own the International Regulatory curriculum and delivery plan—from capability needs assessment and prioritisation to role-based learning pathways (onboarding, core and advanced)—supported by practical job aids and communities of practice. - Program Delivery and Measurement: Form and lead cross-functional project teams to deliver L&D outcomes (needs analysis, solution design, content development, pilots and rollout), ensuring quality, measurable impact and transition to sustainable ownership.
Global Capability Framework Stewardship: Maintain and evolve International Regulatory contributions to global capability/enablement tools, including the Capability Framework, ensuring alignment to roles, proficiency expectations and ways of working for workforce planning and curriculum design.
Learning Ecosystem and Portfolio Management: Drive effective use of the enterprise learning ecosystem and increase visibility of global L&D programs across International Regulatory; manage budgets, vendors and resources; provide leadership, coaching and line management where applicable.
Stakeholder Partnership and Influence: Build strong partnerships across International Regulatory leadership and teams, global regulatory process owners, Digital/IT and other enabling functions to coordinate delivery through a matrix and broader network. -
Broader Contribution: Act as SME or program lead for selected global regulatory capability initiatives where relevant.
Global Scope: Operate across all international markets, coordinating across countries, cultures and time zones.
Essential Skills/Experience:
10+ years experience and understanding of the research and drug development life cycle and of the needs and ways of working of Regulatory Affairs
Experience in the pharmaceutical industry.
University Degree in Science or a related discipline.
Strong leadership skills, including a demonstrated ability to manage stakeholders and influence the broader organization.
Passion for people development
Proven successful leadership and project management experience
Proven ability to develop others to meet personal aspirations and business needs
Proven ability to drive and implement change and improvement projects
Excellent written and verbal communication skills
Experience of working in a global organisation – across countries, cultures, and time zones.
Advanced English proficiency
Desirable Skills/Experience:
Has an in-depth regulatory knowledge and understanding of key regulatory activities and processes, Submission Excellence and Regulatory Operating Model
Professional L&D, training/L&D or project management qualification - Knowledge of AZ business and processes.
Why AstraZeneca: Here, scientific ambition meets real-world urgency. You will be empowered to make bold, evidence-based decisions and move quickly—supported by leaders who expect smart risk-taking and clear outcomes. We bring unexpected teams into the same room—regulatory, digital, quality and learning—so ideas become action faster, and practical solutions reach global teams at scale. When circumstances demand speed, we mobilise and deliver, turning questions into evidence and process into performance in weeks, not months. You will shape how a global regulatory community learns and executes, with access to cutting-edge tools, deep scientific expertise and a collaborative culture that values kindness alongside ambition.
Call to Action: Take the lead in turning regulatory complexity into clarity at global scale—join us to build capability that accelerates delivery and makes a measurable difference for patients.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
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