Regulatory Affairs Director, Digital Projects

About this role

Do you have experience transforming digital processes with AI and automation, supported by knowledge of Regulatory Affairs strategy or policy? If you want to work on innovative projects of high importance for our Respiratory and Immunology (R&I) portfolio, then AstraZeneca is the place for you. Our aspiration is to be pioneers in science, leading in our disease areas to truly transform patient outcomes. This means our people are here to win, and we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines, and patients.

The Global Regulatory Affairs Therapeutic Area (TA) team that you will belong to is a strategic function within the R&I Research and Development (R&D) organization. The Regulatory Affairs team leads the development and execution of regulatory strategies for global programs across the entire lifecycle, proactively leveraging and applying broad regulatory and scientific expertise, leadership skills, and business acumen to identify and champion innovative drug development strategies to benefit patients.

More specifically, you will be part of the Strategy and Innovation Team, which serves as trusted advisors to build an AI-enabled future Regulatory Affairs organization. Our Team comprises a diverse group of individuals including global regulatory strategists, regulatory affairs managers, medical writers, labelling, digital, and policy and intelligence experts to deliver a breadth of capabilities to support the TA and portfolio.

The Digital function within Strategy and Innovation enables a broad and growing remit that includes AI and automation delivery, as well as support of Regulatory systems and data quality. We are on the front lines of transforming our Regulatory Affairs organization to enable data-driven planning and decision support.

The role We now have a great opportunity for you to join our team within Respiratory and Immunology in the role of Regulatory Affairs Director, Digital Projects. This role will lead development and implementation of AI and automation solutions, partner across the business on establishing data and technology foundations, and support front line staff with training and adoption of AI. This role is also critical to credibly liaise across the TAs and with other business partners to drive business-wide initiatives.

What you’ll do The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization, and lifecycle management of the assigned product(s). RADs are accountable for leading the development and implementation of the global regulatory strategy for a product, ensuring the strategy is designed to deliver rapid approval with competitive labelling in line with product considerations, and the needs of the business, markets, and patients.

As Regulatory Affairs Director, Digital Projects, you will be responsible for leading the development and implementation of AI and automation solutions which optimize delivery of Regulatory Projects and meet our Regulatory business priorities. You will partner extensively with Regulatory business leaders to ensure understanding of business needs and opportunities, as well as engaging with other key internal stakeholder groups (e.g., IT, Regulatory Systems, Enterprise AI) to ensure availability of key Regulatory data sources and technologies necessary to support implementation of these solutions. You will also promote adoption of AI and automation throughout R&I Regulatory Affairs as a subject matter expert by holding training sessions, establishing and maintaining standard ways of working, and communicating best practices to Regulatory staff.

The ideal candidate for this role brings a strong background in data science, business intelligence, or a related field, experience leading data analysis projects, a problem solving and continual growth mindset, and experience in either pharmaceutical Regulatory Affairs or working with a Health Authority (e.g., FDA, EMA).

RAD Digital Projects Key Responsibilities include: • Plan, develop, implement, and adopt digital, AI, and automation solutions to support Regulatory Affairs digital objectives, contribute to enterprise regulatory digital initiatives, and enhance performance, in coordination with business leaders • Collaborate with internal stakeholders to ensure availability of key data and technologies necessary to support digital projects, and to support enterprise-wide improvement initiatives • Support digital and AI capability development across our team of Regulatory Affairs professionals through leading training sessions and creating educational resources to promote skill development among non-technical staff • Establish and maintain standard ways of working on digital, AI, and automation projects within Regulatory Affairs, including intake, testing, and version control • Define, track, and monitor performance metrics and KPIs to prioritize and measure the effectiveness of digital projects across Regulatory Affairs • Communicate outcomes of digital projects to business leaders and other internal stakeholders to ensure successful delivery and positive return on investment • Maintain awareness of current and future digital trends in data analytics, Pharma, or other relevant industries to promote continual growth in skills and expertise related to digital, AI, and automation

Minimum Qualifications: • 10 years of experience with a Bachelor’s degree or higher in a science, social science, business, or information sciences discipline, and/or relevant experience in the biopharmaceutical industry • Biopharmaceutical industry experience with demonstrated ability to leverage data and analytics for decision making • Proven technical competence in developing and deploying solutions in support of data and information management (e.g., reports/dashboards, data analyses, curated datasets) • Experience using Generative AI tools to perfo

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