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

Targeting 12 years of progressive experience in Regulatory Affairs, Regulatory Operations, regulatory technology, or a comparable regulated life sciences function, including significant leadership responsibility

Demonstrated success developing and executing regulatory technology, digital enablement, analytics, or enterprise transformation strategies that deliver measurable business outcomes

Deep understanding of global regulatory processes, regulatory content development, submission management, eCTD standards, document and records management, archiving, health authority interactions, and inspection-readiness expectations

Strong experience with Regulatory Information Management and Document Management platforms; experience with Veeva RIM, IQVIA SmartSolve, Lorenz Docubridge or comparable enterprise regulatory platforms is highly valued

Proven strategic and enterprise-minded with the ability to connect long-term regulatory capability strategy with practical execution and near-term business priorities.

Experience leading regulated system implementations, integrations, upgrades, validation, change control, business process design, governance, and lifecycle management in partnership with IT and Quality

Active engagement in regulatory operations, technology, and industry forums, with a strong external network and awareness of emerging practices

Demonstrated experience with organizational change management, stakeholder engagement, training, and adoption of new systems and processes across global, cross-functional organizations, and ability to lead complex change with disciplined governance, clear outcomes, and sustained adoption

Proven people leadership, including developing teams and managing employees, contractors, consultancies, and distributed or remote resources

Exceptional communication, influence, judgment, and executive presence, with the ability to translate complex business and technical issues into clear decisions and practical action

Collaborative and influential to build alignment across Regulatory, IT, Quality, and business functions without relying solely on formal authority

Experience leading AI, machine learning, advanced analytics, knowledge management, workflow automation, structured content, or cloud-enabled regulatory submission initiatives

Surfaces risks early, makes sound decisions, and follows through on commitments

Balances innovation and speed with regulatory, GxP, security, privacy, and inspection-readiness expectations

Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hour