Associate Regulatory Affairs Director, Digital Transformation

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Do you have experience navigating and transforming complex enterprise data into analysis-ready information to enable adoption of 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, Operations, 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 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, Operations, 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 have a great opportunity for you to join our team within Respiratory and Immunology in the role of Associate Regulatory Affairs Director, Digital Transformation. This role will partner with Digital staff and Regulatory Affairs experts to translate business and analytical questions into data requirements, lead development and implementation of automated data pipelines and analysis-ready datasets in cloud data platforms to enable adoption of AI and automation, and monitor data quality to ensure Regulatory Affairs staff make decisions based on complete and trustworthy information. This role will also periodically liaise with cross-TA teams that own and maintain enterprise Regulatory Affairs systems and data products needed to carry out the above tasks.

The role will be based at AstraZeneca’s dynamic R&D hub in Barcelona, Spain.

What you’ll do

The Associate Regulatory Affairs Director (ARAD) provides strategic and operational regulatory leadership to the development, commercialization, and lifecycle management of the assigned product(s). ARADs 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 Associate Regulatory Affairs Director, Digital Transformation, you will be responsible for leading the development and implementation of automated data pipelines and analysis-ready datasets that enable rapid implementation of AI and automation solutions which optimize delivery of Regulatory Projects and meet our Regulatory Affairs business priorities. You will partner extensively with Digital staff and Regulatory Affairs experts to ensure understanding of data requirements, as well as engaging with other key internal stakeholder groups (e.g., Regulatory Systems, IT) to ensure availability of key Regulatory Affairs data sources and technologies necessary to support implementation of automated data pipelines.

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

ARAD Digital Transformation Key Responsibilities include:

• •Design, develop, and implement automated data pipelines and data models to enable rapid adoption of AI and automation solutions to support Regulatory Affairs digital objectives
• •Establish data quality metrics and automated monitoring to ensure the reliability and trustworthiness of analysis-ready data used in AI and automation solutions
• •Collaborate with internal stakeholders to ensure availability of key data sources and technologies necessary to support this work, as well as understanding of data requirements
• •Develop and maintain documentation (e.g., data dictionary, data model) for analysis-ready datasets that can be referenced by Digital staff and other data end users
• •Communicate the quality, trustworthiness, and limitations of analysis-ready data and downstream work products to business leaders and other internal stakeholders to ensure successful data-driven planning and decision support
• •Maintain awareness of current and future trends in analytics and data engineering, data science, biopharmaceuticals, or other relevant industries to promote continual growth in skills and expertise

Essential for the role

• •6 years of experience in analytics engineering, data engineering, data science, or similar large-scale data analysis roles
• •Bachelor’s degree or higher in a science, social science, business, or information sciences discipline, and/or relevant experience in the biopharmaceutical industry
• •Prior biopharmaceutical industry experience in Regulatory Affairs, with a Health Authority (e.g., FDA, EMA), or in other settings that required extensive knowledge of drug and biologic regulatory requirements
• •Experience designing, developing, and implementing automated data pipelines and data models to transform enterprise data into analysis-ready datasets in cloud data platforms such as Snowflake, Databricks, or similar technologies
• •Experience implementing automated data quality checks and monitoring to ensure the reliability and trustworthiness of analysis-ready data
• •Expert in Python and SQL for data pipeline development and orchestration, including experience using AI-supported coding for rapid prototyping
• •Good software development practices, such as code version control with Git, reusable code design, and automated testing
• •Able to translate ambiguous business and analytical questions into data requirements and technical solutions, working with Regulatory Affairs SMEs, data scientists, platform teams, and system owners
• •Able to self-start and independently investigate unfamiliar data sources and complex data models to identify relevant data for analysis

Desirable for the role

• •Experience working with data from Veeva RIM systems
• •Experience extracting or transforming unstructured information into structured data using techniques such as document parsing, Large Language Models (LLMs), or Natural Language Processing (NLP)
• •Familiarity with public health or Health Authority datasets, such as information available through the FDA and EMA websites
• •Experience establishing or driving standard ways of working for a technical team
• •Working knowledge of statistical analysis, machine learning, or other data analysis techniques leveraged by downstream AI and automation use cases
• •Experience developing Business Intelligence (BI) dashboards from enterprise data in PowerBI, Tableau, or similar tools
• •Knowledge of the R&I TA and a broad understanding of regulatory and drug development activities

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we