Associate Regulatory Affairs Director, Digital Transformation

About the role

AstraZeneca is looking for an Associate Regulatory Affairs Director, Digital Transformation, based at its Barcelona R&D hub. The role partners with Digital staff and Regulatory Affairs experts to turn business and analytical questions into data requirements, and to lead the development and implementation of automated data pipelines and analysis-ready datasets in cloud data platforms so that AI and automation can be adopted. It works with cross-TA teams that own enterprise Regulatory Affairs systems and data products. The position is split between 3 days in the office and 2 days working from home.

Key responsibilities

• Lead the development and implementation of automated data pipelines and analysis-ready datasets that enable rapid adoption of AI and automation solutions for Regulatory Affairs.
• Design, develop and implement automated data pipelines and data models, and establish data quality metrics and automated monitoring to ensure reliable, trustworthy data.
• Collaborate with internal stakeholders such as Regulatory Systems and IT to secure the data sources and technologies needed.
• Maintain documentation such as data dictionaries and data models for analysis-ready datasets.
• Communicate the quality, trustworthiness and limitations of the data to business leaders and stakeholders.
• Stay aware of trends in analytics, data engineering, data science and biopharmaceuticals.

Required profile

• 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 biopharmaceutical industry experience.
• Prior biopharmaceutical Regulatory Affairs experience, with a Health Authority (e.g. FDA, EMA) or in other settings requiring extensive knowledge of drug and biologic regulatory requirements.
• Experience designing automated data pipelines and data models in cloud platforms such as Snowflake or Databricks.
• Experience implementing automated data quality checks and monitoring.
• Ability to translate ambiguous business questions into data requirements and technical solutions, and to work independently with unfamiliar data sources.

Required skills

• Expert in Python and SQL for data pipeline development and orchestration, including AI-supported coding for rapid prototyping.
• Git, reusable code design and automated testing.
• Desirable: Veeva RIM, document parsing, LLMs and NLP, BI dashboards in PowerBI or Tableau, and knowledge of the Respiratory and Immunology therapeutic area.