Senior Director, Regulatory Affairs Management – Infectious Diseases

As Senior Director, Regulatory Affairs Management for the Infectious Disease Unit, you will lead and develop the Regulatory Affairs Management team and set the strategic direction for regulatory delivery across the Infectious Disease portfolios. As a member of the ID Regulatory Affairs Leadership Team, you will partner with Regulatory Affairs colleagues globally to ensure high-quality, compliant submission delivery, strengthen organizational capability, and advance continuous improvement. Accountabilities • Oversee regulatory project management and operational delivery for development-stage and approved products across the global Infectious Disease portfolio • Lead and develop the Infectious Disease Regulatory Affairs Management team through direct and indirect people leadership, coaching, performance management, succession planning and recruitment, and represent the team across the broader Regulatory Affairs organization • Define and implement regulatory submission models that improve efficiency, quality and value, and secure organizational support for their adoption • Ensure regulatory milestones, submissions and compliance activities are planned, forecast, reported and delivered to required quality standards and timelines • Build effective internal and external partnerships and represent AstraZeneca, as appropriate, with health authorities, trade associations and other regulatory organizations • Represent Infectious Disease Regulatory Affairs in driving cross-functional alignment, effective decision-making and execution of strategic and operational objectives • Lead strategic planning and operational coordination activities, including overseeing team resources and headcount, guiding priorities and assignments as business needs evolve, ensuring regulatory fees and other departmental costs are accurately forecasted, monitored and managed to support delivery within approved budget targets, contributing to business cycle planning, and supporting organizational readiness • Ensure accurate Infectious Disease Regulatory Affairs resource and cost projections are developed in collaboration with departmental leadership and functional partners for timely integration into enterprise-level processes and other purposes • Serve as a key business partner to Regulatory Affairs leadership by driving cross-functional alignment, enabling effective governance and decision-making, and ensuring execution of key strategic and operational objectives • Monitor evolving global and regional regulatory submission operational requirements, assess their implications for the Infectious Disease portfolio and advise stakeholders on strategic operational opportunities, risks and required actions • Lead the development and improvement of global regulatory policies, processes and capabilities, promoting knowledge sharing and consistent, efficient ways of working across the Regulatory Affairs Management community • Model AstraZeneca values and foster an inclusive, courageous and high-performing team that delivers effectively across functions, geographies and cultures Minimum Qualifications • Bachelor’s degree in a science related field • At least 10 years of regulatory affairs experience in the biopharmaceutical industry, a related sector or a health authority, including leadership of regulatory or cross-functional teams • Proven ability to apply global and regional regulatory requirements to plan and deliver major submissions, manage compliance obligations and support products across the lifecycle • Demonstrated success leading and developing regulatory professionals through coaching, performance management and succession planning • Strong project, portfolio and resource management skills, with the ability to set priorities and deliver through g