AstraZeneca has prioritized digital in R&D as a critical strategic area of focus by 2025, as part of the overall company strategy. Our ambition is to transform healthcare, powered by digital, science and collaborations, to deliver the healthcare outcomes and experience that patients care about the most.

Within Respiratory & Immunology (R&I) Regulatory Affairs, we work in areas of unmet medical need, taking innovative regulatory approaches to bring life-changing treatments to those who need them. We constantly look for new and innovative approaches across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We’re growing fast and are as focused and committed to the development of our people as we are to our business goals– providing an open and supportive space to explore, learn and grow across all roles and levels.

In line with our strategic ambition, we are introducing a role focusing on Digital Technology and Information, which will be responsible for contributing to all digital and technical aspects of our regulatory function. This role will support development of the digital strategic roadmap and will input to  the enterprise wide regulatory information management roadmap;  identification of use cases involving the application of AI machine learning and oversee implementation of these cases in partnership with AstraZeneca’s technology, digital health and development groups.

What you will be doing:

• Point of contact for R&I Regulatory to different digital projects, for example Enterprise Regulatory Vault (ERV), in close collaboration with current subject matter experts across Regulatory Affairs.
• Provide data science expertise and recommend data science solutions which contribute to enterprise regulatory digitalization of end to end business processes
• Identify R&I regulatory’ s system enhancement priorities, and monitor to ensure their effective delivery
• Contribute to identification of emerging technologies, their application across Regulatory Affairs and input to our innovative regulatory informatics strategy to harness and support Late R&I Regulatory
• Identify specific use cases where AI machine learning algorithms can be applied and oversee implementation along with AstraZeneca’s technology and development groups.
• Contribute to the identification of key data sources of interest to Late R&I Regulatory, maintaining a roadmap of future data assets including regulatory data and associated late stage development.
• Drive cultural and behavioral change across the business to address data quality and ownership
• Independently keeps own knowledge up to date and learns from senior team members, proposing appropriate training courses for functional development.
• Champion R&I regulatory’ s relationship with aligned technology development groups, collaborate in a multidisciplinary environment with world leading regulatory and data scientists, statisticians and IT professionals.

Essential for the role:

• Degree in Life Sciences, Pharmacy, or Medicine or another relevant business discipline
• Previous life science or healthcare experience
• Regulatory scientific background, a depth and breadth of analyzing of data
• Experience of engaging with Regulatory bodies
• Effective project and resource management; proven ability to handle a broad range of customers and team members
• Biopharmaceutical industry experience with demonstrated ability to leverage data and analytics for decision making
• Understanding of analytics landscape in the Pharma/biotech industry
• Understanding of Drug development information value chain
• Ability to disseminating complex information to a wide audience

Desirable for the role:

• Previously worked with big data and data science with an ability to derive data insights
• Knowledge of Python or R or related programming languages
• Experience with Waterfall, Agile and Hybrid project management methodologies
• Background in regulatory affairs with knowledge of the drug development process, in particular, regulatory documentation, submission, publishing and approval processes

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.