• Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs • Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities • Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems • Identify, communicate, and escalate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership • Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide

• Responsible for the financial and operations oversight of clinical delivery across a portfolio of studies. • Partner with Regional Heads within the Clinical Network to ensure appropriate resourcing and productivity levels within the portfolio of studies. • Ensures that assigned clinical staff understand and perform consistently according to defined operational, financial, and quality performance and process standards. • Maximize contribution margin across clinical delivery through strong financial stewardship and accountability across the portfolio of studies. • Uses established operational, financial and quality metrics and reporting dashboards to assess overall portfolio health and take action where necessary. • Participates in risk management activities across the assigned portfolio of studies. • Drives and supports and facilitates a learning organization. • Engages with leadership to help drive and implement initiatives which aim to improve performance of the business. • Helps to define and implement the company and department vision and strategy; translates this into key initiatives and priorities.

• Own execution planning and alignment for initiatives that span multiple Therapeutic Areas or do not sit within a single TA • Coordinate execution across enterprise and system accounts (e.g., IDNs), ensuring consistent prioritization and engagement approach • Serve as the primary owner for enterprise-level execution challenges and escalations that fall outside TA boundaries • Ensure execution plans are forward-looking, anticipating future needs rather than reacting to current issues • Shape cross-TA initiatives upstream, ensuring sequencing, readiness, and dependencies are clearly defined before execution • Identify emerging system-level risks and misalignments and proactively drive resolution • Align stakeholders across Therapeutic Areas and functions to ensure enterprise-level consistency • Resolve conflicts in priorities, timing, or execution expectations across TA boundaries • Own resolution of complex cross-TA execution issues requiring enterprise-level coordination • Drive structured issue management, ensuring clarity of ownership and follow-through

• Ensure end‑to‑end execution outcomes are owned and delivered across assigned Therapeutic Areas through a team of Field Execution Leads, spanning steady‑state operations, launches, and enterprise change initiatives • Hold Field Execution Leads accountable as the single points of execution ownership for their assigned Therapeutic Areas, ensuring priorities are delivered with clarity, sequencing, and follow‑through • Oversee execution health across Therapeutic Areas, identifying systemic risks, recurring friction, and execution breakdowns that require intervention beyond a single TA • Ensure Field Execution Leads accurately interpret execution health and drive timely decisions and corrective actions based on standardized business review outputs • Ensure escalation paths, decision rights, and governance are applied consistently, and that execution issues are resolved once and at the system level, rather than repeatedly across TAs • Partner with planning, enablement, and infrastructure teams to ensure execution prerequisites (processes, tools, training, sequencing) are consistently validated prior to field deployment across Therapeutic Areas • Serve as a senior execution partner to Therapeutic Area leadership, reinforcing a shared enterprise execution system while preserving TA‑specific priorities and constraints • Lead, coach, and develop a team of Field Execution Leads, setting clear expectations for execution ownership, decision discipline, and accountability • Calibrate execution judgment across the team, ensuring consistent standards for escalation, risk management, and resolution