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 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 Regulatory Affairs Director Digital Projects, you will be accountable for the development and implementation of digital strategies and digital project 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 encompassing 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 that 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:

• Batchelor’s degree or higher in a science business or information sciences discipline, and/or relevant experience in the bio-pharmaceutical industry
• 5+ years of experience and proven technical competence in developing and deploying solutions in support of data and information management
• Advanced Analytics (Including AI/ML) capabilities, including use of AI agents
• Expertise in decision science and/or qualitative and quantitative research methods.
• Proficient in data impact analysis, strategic thinking, creative problem solving and excellent oral and written communication skills.
• Experience of regulatory drug development or equivalent, and experience with major Health Authority interactions
• Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
• A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
• Detailed understanding of US and/or European regulatory affairs and an understanding of the broader regulatory ecosystem.
• Experience working cross-functionally with diverse stakeholders.
• Experience working in BioPharmaceutical development including but not limited to, pharmaceutical/biotech industry and government.

Desirable Qualifications:

• Solid understanding of the commercial aspects of BioPharmaceutical development
• Knowledge of the R&I therapeutic area.
• A broad understanding of regulatory and drug development activities.
• Cost / benefit analysis and / or business case development experience
• Experienced in Python and Machine Learning
• Broad background of experience working in pharmaceutical business and prior experience in leading competitive intelligence within the pharmaceutical industry or in associated industries
• Previous experience in working with external trade and scientific associations.

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $186,232.80 - $279,349.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.