Regulatory Affairs Director, Digital Projects

Regulatory Affairs Director Digital Projects

Do you have knowledge in Regulatory Affairs Strategy and Policy, underpinned with experience in Digital Strategy development and digital project leadership? 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-read 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 Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned product(s). RADs 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 a Regulatory Affairs Director Digital Projects, you will be accountable for the development and implementation of digital strategies and digital projects 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 partnering extensively with other key internal stakeholder groups (e.g., Regulatory Intelligence & Decision Support, IT, Regulatory Systems, Data Strategy and AI, etc.) and with key external industry partners / peers / agencies to ensure delivery and implementation of Regulatory Digital projects which encompass people, process and technology.

You will also work with Regulatory Intelligence & Decision Support colleagues to help provide structured information and data source which support automation of key regulatory activities including for example development of regulatory strategies, as well as adoption of digital technologies across a range of regulatory activities. The RAD Digital Projects must have the ability to assess opportunities, prioritize and lead projects which align with our automation ambition, so must have a strong background in leveraging data and technology to improve operational effectiveness, data science and technical leadership, as well as Regulatory Affairs.

RAD Digital Projects Key Responsibilities Include :

• Development and implementation of a digital strategy that supports the Regulatory mission and objectives
• Partnering with existing digital initiative leads to leverage innovative technology, people and process improvement opportunities for increased business value across Regulatory.
• Collaborate with internal and external stakeholders (IT, Process, Change Mgmt., and Regulatory bodies / consortia / vendors) to ensure digital strategies meet current regulatory requirements and future industry expectations.
• Innovation : Identify and implement innovative digital solutions to address business priorities.
• Support digital and AI capability development across our team of Regulatory professionals, fostering a culture of continuous improvement and professional development.
• Utilize data analytics and reporting tools to measure the effectiveness of digital strategies and make data-driven decisions.
• Proficient on current and future digital trends across Pharma or other relevant industries to ensure the Regulatory Digital Strategy remains relevant and competitive.
• Provide digital leadership and participate in coaching, and capability build for adoption of AI platform by Regulatory Project teams.
• Partner with Regulatory Intelligence and Decision Support to provide analysis on EMA, FDA, and / or other global Health Authority trends, perspectives, reports, analyses, activities, etc.
• Identify potential opportunities for adoption of novel technology or other innovative tools to enhance regulatory intelligence and strategic analysis.

Minimum Qualifications :

Desirable Qualifications :

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking methods, and bringing unexpected teams together. Interested? Come and join our journey.

So, What's Next?

Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.