Director, Regulatory Affairs Advanced Technology Enablement

AbbVie • North Chicago, IL

1d

About The Position

The Director, Regulatory Affairs Advanced Technology Enablement is responsible for shaping, owning, and executing the Regulatory Affairs (RA) AI roadmap, driving strategic initiatives that embed artificial intelligence and automation within the global RA organization. This leader will serve as the key subject matter expert for regulatory AI, guiding the practical and future-focused application of AI technologies to enhance regulatory efficiency, enable organizational transformation, and foster a culture of innovation. The Director will actively bridge enterprise-level AI directives into actionable RA strategies, partnering closely with Communications & Change Management and Training teams to ensure effective knowledge transfer, change enablement, and continuous team upskilling.

Requirements

• Advanced degree (MS/PhD, PharmD, or similar preferred) in life sciences, engineering, data science, or related discipline
• Significant experience (8+ years) in pharmaceutical regulatory affairs, digital transformation, or AI strategy roles
• Demonstrated experience developing, leading, and executing strategic technology or AI roadmaps in a regulated environment
• Deep knowledge of regulatory processes, requirements, and platforms in pharma or biotech
• Proven ability to champion and accelerate change, with strong stakeholder engagement and influencing skills across all levels
• Expertise with artificial intelligence, machine learning, and automation technologies as applied within compliant, global organizations
• Outstanding communication skills—capable of translating complex AI topics into clear, actionable guidance for business and technical stakeholders
• Continual learning mindset; vigilant understanding of external AI developments, competitor landscape, and emerging health authority expectations

Responsibilities

• Full ownership and continuous refinement of the RA AI roadmap—driving strategic prioritization, execution, and organizational alignment around AI initiatives
• Lead the identification, scoping, and delivery of high-impact AI and automation initiatives within Regulatory Affairs, ensuring measurable benefit and alignment to business strategy
• Act as the primary subject matter expert and visionary for the use of AI across Regulatory Affairs, ensuring integration of best practices and innovative approaches
• Serve as a critical stakeholder and thought leader in enterprise and cross-functional forums on AI policy, strategy, and system integration
• Partner with RA Communications & Change Management to co-create and implement robust change strategies that accelerate adoption and minimize disruption
• Partner with RA Training to design and deploy relevant training, upskilling, and continuous learning programs tailored to AI adoption
• Enable effective cross-functional collaboration, engaging BTS, Innovation, and enterprise AI teams to champion the integration of AI into existing RA systems and processes
• Monitor and translate external AI trends (peer pharma, biotech, and health authorities) into actionable insights and opportunities for the RA organization
• Develop and maintain relevant communications, advocacy, and resource materials to drive understanding, transparency, and excitement for AI-enabled transformation across RA
• Track, measure, and report progress of AI initiatives and roadmap milestones to senior leadership and stakeholders

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs

What This Job Offers

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