Regulatory Affairs Director, Digital Projects

About the role

The role of Regulatory Affairs Director, Digital Projects involves leading the development and implementation of AI and automation solutions, partnering across the business on establishing data and technology foundations, and supporting front-line staff with training and adoption of AI.

Responsibilities

• 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.
• 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.

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).

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.
• 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.
• A broad understanding of regulatory and drug development activities.