Associate Regulatory Affairs Director, Digital Projects

AstraZeneca • Gaithersburg, MD

1d

About The Position

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, as well as engaging with other key internal stakeholder groups (e.g., Regulatory Intelligence & Decision Support, IT, Regulatory Systems, Data Strategy and AI, etc.) to ensure availability of key Regulatory data sources and technologies necessary to support implementation of these solutions.
The ideal candidate for this role brings a strong background in data analysis and/or business intelligence, a problem solving and continual growth mindset, and experience in either Regulatory Affairs or working with a Health Authority (e.g., FDA, EMA).

Requirements

• 7 years of experience with Bachelor’s degree or higher in a science, social science, business, or information sciences discipline, and/or relevant experience in the bio-pharmaceutical 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, 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 AI and automation prototypes and operational solutions, including low/no code AI and automation platforms, occasional custom scripting (e.g., Python, VBA, SQL), and business productivity software (e.g., Microsoft Office)
• Expertise in statistical analysis and performance measurement, including quantifying return on investment
• Proficient in strategic thinking, creative problem solving, and excellent oral and written communication skills.
• Experience with regulatory drug development or equivalent, or experience with major Health Authorities, 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, governance) and non-technical staff (medical and scientific experts)

Nice To Haves

• 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
• Solid understanding of the commercial aspects of Biopharmaceutical development
• Knowledge of the R&I therapeutic area and a broad understanding of regulatory and drug development activities

Responsibilities

• Develop and implement digital, AI, and automation solutions to support the Regulatory Affairs digital objectives, contribute to enterprise regulatory digitalization, and enhance performance, in coordination with business leaders
• Collaborate with internal stakeholders (e.g., IT, Data, Process, Change Management, and vendors) 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 professionals through leading training sessions and creating other educational resources to promote skill development among non-technical staff
• 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 AI and automation

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director