Regulatory Affairs Director, Digital Projects

AstraZeneca • Gaithersburg, MD

9d • Onsite

About The Position

AstraZeneca is seeking a Regulatory Affairs Director, Digital Projects to join their Respiratory and Immunology (R&I) portfolio. This role is crucial for transforming digital processes using AI and automation, with a strong emphasis on Regulatory Affairs strategy and policy. The successful candidate will work on innovative projects of high importance, contributing to AstraZeneca's aspiration to be pioneers in science and transform patient outcomes. The Global Regulatory Affairs Therapeutic Area (TA) team is a strategic function within the R&I Research and Development (R&D) organization, responsible for leading the development and execution of regulatory strategies across the product lifecycle. The Strategy and Innovation Team, where this role resides, focuses on building an AI-enabled future for Regulatory Affairs, comprising experts in global regulatory strategy, regulatory affairs management, medical writing, labeling, digital, and policy. The Digital function within this team is at the forefront of transforming Regulatory Affairs to enable data-driven planning and decision support.

Requirements

• 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).

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.
• 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.

Responsibilities

• Lead development and implementation of AI and automation solutions which optimize delivery of Regulatory Projects and meet Regulatory business priorities.
• Partner extensively with Regulatory business leaders to understand business needs and opportunities.
• Engage 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.
• 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.
• 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.
• Support digital and AI capability development across the team of Regulatory Affairs professionals through leading training sessions and creating educational resources.
• 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• 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