Sr. Director, Regulatory Affairs, Technology & Transformation at Acadia Pharmaceuticals · LumiJobs

Responsibilities

Develop and execute Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs objectives, corporate pillars, portfolio needs, and regulatory requirements
Establish governance, prioritization, investment, and value-realization frameworks for technology and transformation initiatives, with clear roadmaps, ownership, dependencies, risks, and success measures
Serve as a trusted advisor to Regulatory and senior enterprise leaders on capability priorities, emerging technologies, organizational readiness, and sustainable operating-model change. Identify, evaluate, prioritize, and responsibly implement opportunities involving AI, advanced analytics, automation, digital authoring, structured content, and decision-support capabilities
Provide business leadership for the effective deployment, advancement, integration, validation, maintenance, training and adoption of regulatory information and document management capabilities, including RIM, DMS, publishing, submission, archiving, commitment tracking, and reporting solutions
Partner with IT, Quality, Regulatory Operations, and business stakeholders to define user requirements, select and implement systems, manage upgrades and change controls, and maintain compliant, inspection-ready solutions. Advance interoperable regulatory data and content capabilities, including structured content, knowledge management, analytics, workflow automation, cloud-enabled submissions, APIs and connectors, and responsible AI/ML use cases
Ensure regulatory platforms interface effectively with other relevant GxP and enterprise systems to enable secure, efficient information exchange across Clinical, Quality, Technical Operations, Commercial, Program Management, and related functions
Lead the design, digitization, implementation, and continuous improvement of end-to-end regulatory processes, reducing manual effort, cycle time, rework, and operational risk while improving predictability and user experience
Oversee relevant policies, SOPs, work instructions, standards, job aids, training, and governance practices that support consistent, compliant execution across regions and programs
Use metrics, analytics, assessments, and user feedback to identify improvement opportunities and demonstrate measurable business outcomes
Lead organizational change management, stakeholder engagement, communications, training, and adoption strategies that embed new capabilities and ways of working
Foster a culture of innovation, continuous learning, disciplined experimentation, and accountability while ensuring innovation remains grounded in business needs and compliance expectations
Monitor external regulatory technology trends, evolving health authority expectations, industry practices, and peer networks to inform capability investments and strategic direction

Sr. Director, Regulatory Affairs, Technology & Transformation

Responsibilities

Qualification

Required

Benefits

Company

Acadia Pharmaceuticals

More roles at Acadia Pharmaceuticals