Senior Director Global Regulatory, Digital
AstraZeneca · Maryland
📍 US - Gaithersburg - MDvia workdayFirst listed here 2026-09-25
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Job Title: Senior Director Global Regulatory, Digital
Location: Gaithersburg
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to Role:
The Senior Director, Global Regulatory Digital Strategy is accountable for the development and implementation of a robust digital strategy which aligns to and meets the needs of the Global Regulatory business . In this role, you will partner extensively with senior Regulatory business leaders to ensure understanding of business priorities and needs . You will also partner extensively with other key internal stakeholder groups (e.g., IT, Enterprise AI Unit, Enterprise Data Office, Regulatory Systems, Process Excellence , Change Mgmt., Finance, etc. ) as well as drive collaboration with key external industry partners / peers / agencies to ensure delivery and implementation of a robust Global Regulatory Di gital St rategy encompas s ing people, process and technology .
You will lead the development and implementation of a Global Regulatory data strategy that enables successful achievement of the overall Digital strategy . To assure success in this space, you will work closely with and influence other internal Regulatory data teams as well as data offices across R&D , IT and at the AZ-enterprise level.
You will also lead a team of digital product owners that will assist in strategy development as we ll as drive the successful achievement of annual strategy goals . You will mentor and guide these resources to ensure continuous learning and effective engagement to drive strategy delivery to plan and timelines .
This leadership role will also ensure proper digital governance in collaboration with the Regulatory Technology Governance Council (RTGC) and Regulatory Management Board (RMB) . Th e Senior Director, Global Regulatory Digital Strategy will drive the evolution and continued improvement of both the RTGC as well as Regulatory’s Global digital portfolio management capabilities to ensure and safeguard successful achievement of the Global Regulatory Digital Strategy.
As the Senior Director, Global Regulatory Digital Strategy, you will bring strong Regulatory and leadership skills as well as extensive demonstrated success in the digital arena (e.g., AI , agentic AI, data , digital strategies, product ownership, etc.) .
Accountabilities:
Strategic Leadership: Develop and implement a digital strateg y (data strategy inclusive) that support s the R egulatory mission and objectives , ensuring alignment with organizational goals.
Digital Transformation : Partner with digital initiative sponsor s to leverag e innovative technology , people and process improvement opportunities to drive speed, efficiency, transparency, and increased business value across Regulatory.
Stakeholder Engagement: Collaborate with internal and external stakeholders (IT, Process, Change Mgmt. , and R egulatory bodies /consortia/vendors ) to ensure digital strategies meet current regulatory requirements and future industry expectations.
Innovation: Identify and implement innovative digital solutions to that address business priorities .
Team Management: Lead and mentor a team of digital professionals focused on delivery of innovation use cases while fostering a culture of continuous improvement and professional development.
Data & Analytics : Design and deliver a robust data foundation that enables advanced AI and analytics capabilities across Global Regulatory. Utilize data analytics and reporting tools to measure the effectiveness of digital strategies and make data-driven decisions.
Compliance: Ensure all digital initiatives are compliant with regulatory standards and best practices.
Governance: Lead the development and evolution of d igital governance and portfolio delivery capabilities to safeguard and ensure achievement of business value that aligns with the digital strategy.
Digital Expertise : Proficient on current and future digital trends across Pharma or other relevant industries to ensure the Regulatory Digital Strategy remains relevant and competitive.
Fiscal Mgmt. : Oversee all financial aspects related to the digital team and portfolio.
Lifecycle Management: Partner with Regulatory Systems team to define and ensure appropriate product owner transition s from innovation team to product maintenance team
Essential Skills/Experience:
Bachelor’s degree in AI/ML, data science or a related field
7+ years ’ leadership experience in digital transformation in healthcare , Pharma or a drug development environment
5+ years’ experience in portfolio management and governance
Demonstrated ability to lead, influence, and inspire teams towards achieving strategic goals.
Strong ability to work collaboratively with various stakeholders, including regulatory bodies and senior l
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