Regulatory Affairs Director, Digital Projects

Do you have experience transforming digital processes with AI and automation, supported by knowledge of Regulatory Affairs strategy or policy? 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, and 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 (TA) team that you will belong to is a strategic function within the R&I Research and Development (R&D) 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 serves as trusted advisors to build an AI-enabled future Regulatory Affairs organization. Our Team comprises a diverse group of individuals including global regulatory strategists, regulatory affairs managers, medical writers, labelling, digital, and policy and intelligence experts to deliver a breadth of capabilities to support the TA and portfolio.

The Digital function within Strategy and Innovation enables a broad and growing remit that includes AI and automation delivery, as well as support of Regulatory systems and data quality. We are on the front lines of transforming our Regulatory Affairs organization to enable data-driven planning and decision support.

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 will lead development and implementation of AI and automation solutions, partner across the business on establishing data and technology foundations, and support front line staff with training and adoption of AI. This role is also critical to credibly liaise across the TAs and with other business partners to drive business-wide initiatives.

What you’ll do

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization, and lifecycle management of the assigned product(s). RADs are accountable for leading the development and implementation of the 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 responsible for leading 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, as well as engaging with other key internal stakeholder groups (e.g., IT, Regulatory Systems, Enterprise AI) to ensure availability of key Regulatory data sources and technologies necessary to support implementation of these solutions. You will also promote adoption of AI and automation throughout R&I Regulatory Affairs as a subject matter expert by holding training sessions, establishing and maintaining standard ways of working, and communicating best practices to Regulatory staff.

The ideal candidate for this role brings a strong background in data science, business intelligence, or a related field, experience leading data analysis projects, a problem solving and continual growth mindset, and experience in either pharmaceutical Regulatory Affairs or working with a Health Authority (e.g., FDA, EMA).

RAD Digital Projects Key Responsibilities include:

• Plan, develop, implement, and adopt digital, AI, and automation solutions to support Regulatory Affairs digital objectives, contribute to enterprise regulatory digital initiatives, and enhance performance, in coordination with business leaders
• Collaborate with internal stakeholders to ensure availability of key data and technologies necessary to support digital projects, and to support enterprise-wide improvement initiatives
• Support digital and AI capability development across our team of Regulatory Affairs professionals through leading training sessions and creating educational resources to promote skill development among non-technical staff
• Establish and maintain standard ways of working on digital, AI, and automation projects within Regulatory Affairs, including intake, testing, and version control
• Define, track, and monitor performance metrics and KPIs to prioritize and measure the effectiveness of digital projects across Regulatory Affairs
• Communicate outcomes of digital projects to business leaders and other internal stakeholders to ensure successful delivery and positive return on investment
• Maintain awareness of current and future digital trends in data analytics, Pharma, or other relevant industries to promote continual growth in skills and expertise related to digital, AI, and automation

Minimum Qualifications:

• 10 years of experience with a Bachelor’s degree or higher in a science, social science, business, or information sciences discipline, and/or relevant experience in the biopharmaceutical industry
• Biopharmaceutical industry experience with demonstrated ability to leverage data and analytics for decision making
• Proven technical competence in developing and deploying solutions in support of data and information management (e.g., reports/dashboards, data analyses, curated datasets)
• Experience using Generative AI tools to perform day-to-day work tasks, including prompt and/or context engineering, agent development, and understanding of key limitations and design considerations, such as human-in-the-loop
• Experience utilizing a wide range of tools and technologies to deliver tangible digital, AI, and automation prototypes and operational solutions, including low/no code AI and automation platforms, and occasional custom scripting (e.g., Python, VBA, SQL)
• Proficient in strategic thinking, creative problem solving, and excellent oral and written communication skills.
• Experience initiating, leading, and coordinating analysis, planning, or process improvement efforts involving multiple junior staff
• Experience with regulatory drug development or equivalent, or experience with a Health Authority, including an understanding of guiding principles in drug development and the US and/or European regulatory ecosystems
• Experience working cross-functionally with diverse stakeholders, including both technical staff (e.g., IT, data) and non-technical staff (medical and scientific experts)

Desirable Qualifications:

• Moderate or higher skill in computer programming, such as Python, VBA, or SQL, including project experience using at least one of these programming languages
• Experience developing agentic AI workflows connected to data or other content
• Experience working with commonly used Regulatory Affairs datasets or systems, including RIM platforms and Health Authority datasets
• Knowledge of advanced analytics and machine learning, including validation and cross-validation approaches, natural language processing, neural network architectures, or similar
• Track record of interfacing with senior leadership on high-visibility digital, AI, and automation initiatives to communicate progress and findings
• Solid understanding of the commercial aspects of Biopharmaceutical development
• Knowledge of the R&I TA and a broad understanding of regulatory and drug development activities

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.

Where can I find out more?

AZ Gaithersburg

Respiratory & Immunology

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.