Associate Regulatory Affairs Director, Digital Projects
AstraZenecaAbout the role
Do you have knowledge in Regulatory Affairs Strategy and Policy, underpinned with experience transforming Digital processes with AI and automation?
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, 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 team that you will belong to is a strategic function within the Respiratory & Immunology Development 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 comprises a diverse group of individuals including global regulatory strategists, medical writers, labelling, data analytics, and policy and intelligence areas to deliver a breadth of capabilities to support the TA and portfolio while driving a future-ready Regulatory organization.
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 is critical to drive development of capabilities for the use of automation, AI, and digital, driving the effective use of current digital tools within R&I Regulatory to simplify and improve delivery. This role is also critical to credibly liaise across the TAs to drive business-wide initiatives for a future-proof organization.
What you’ll do
The Associate Regulatory Affairs Director (ARAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned product(s). ARADs are accountable for leading the development and implementation of the regional or 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 Projects, you will be responsible for 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
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