Senior Director Global Regulatory, Digital

AstraZeneca•Gaithersburg, MD

1d•$212,994 - $319,441•Hybrid

About The Position

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 Digital Strategy encompassing 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 well 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). The 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.).

Requirements

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 leadership.
A forward-thinking mindset with a passion for leveraging technology to drive change.
Proficient in using data to drive strategic decisions and measure outcomes.
A thorough understanding of regulatory compliance and the ability to ensure digital initiatives meet these standards

Responsibilities

Develop and implement a digital strategy (data strategy inclusive) that supports the Regulatory mission and objectives, ensuring alignment with organizational goals.
Partner with digital initiative sponsors to leverage innovative technology, people and process improvement opportunities to drive speed, efficiency, transparency, and increased business value across Regulatory.
Collaborate with internal and external stakeholders (IT, Process, Change Mgmt., and Regulatory bodies/consortia/vendors) to ensure digital strategies meet current regulatory requirements and future industry expectations.
Identify and implement innovative digital solutions to that address business priorities.
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.
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.
Ensure all digital initiatives are compliant with regulatory standards and best practices.
Lead the development and evolution of digital governance and portfolio delivery capabilities to safeguard and ensure achievement of business value that aligns with the digital strategy.
Proficient on current and future digital trends across Pharma or other relevant industries to ensure the Regulatory Digital Strategy remains relevant and competitive.
Oversee all financial aspects related to the digital team and portfolio.
Partner with Regulatory Systems team to define and ensure appropriate product owner transitions from innovation team to product maintenance team.