Sr. Director, Regulatory Affairs, Technology & Transformation

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

Please note that this position can be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Sr. Director, Regulatory Affairs, Technology & Transformation is a strategic role within Regulatory Operations responsible for defining and executing the technology, data, training, and transformation agenda for Global Regulatory Affairs. The role modernizes regulatory processes and capabilities through fit-for-purpose platforms, digitization, automation, analytics, artificial intelligence, structured content, and innovative ways of working. This leader connects business strategy with operational execution, ensuring solutions are compliant, scalable, adopted by users, and focused on measurable improvements in quality, speed, transparency, and organizational effectiveness.

Primary 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
• Communicate progress, benefits, risks, decisions, and lessons learned clearly to technical, operational, and executive audiences
• Other responsibilities as assigned

Education/Experience/Skills

• Bachelor’s degree in life sciences, information systems, business, engineering, or a related field; advanced degree preferred. An equivalent combination of relevant education and experience may be considered

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