Sr. Director, Regulatory Affairs, Technology & Transformation

Acadia Pharmaceuticals Inc.•San Diego, CA

3d•$220,600 - $275,700•Hybrid

About The Position

The Sr. Director, Regulatory Affairs, Technology & Transformation is a strategic leader 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. It connects business strategy with operational execution and ensures solutions are compliant, scalable, adopted by users, and focused on measurable improvements in quality, speed, transparency, and organizational effectiveness. The role develops regulatory technology strategy and governance; advises Regulatory and enterprise leaders; and provides business leadership for regulatory information and document-management capabilities. In partnership with IT, Quality, Regulatory Operations, and business stakeholders, it supports system selection, implementation, integration, validation, maintenance, training, and adoption, while advancing interoperable regulatory data and content capabilities. The position also leads process improvement, organizational change management, and continuous learning across global, cross-functional teams. The position may be based in San Diego, San Francisco, or Princeton. Acadia's hybrid model requires working in an office three days per week on average. Domestic and international travel may be required. The role includes regular standing, walking, sitting, and equipment use, occasional lifting or moving of up to 20 pounds, and the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

Requirements

Bachelor’s degree in life sciences, information systems, business, engineering, or a related field; 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 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; 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.
Ability to collaborate and build alignment across Regulatory, IT, Quality, and business functions without relying solely on formal authority.
Ability to surface risks early, make sound decisions, and follow through on commitments.
Ability to balance innovation and speed with regulatory, GxP, security, privacy, and inspection-readiness expectations.
Willingness and ability to travel domestically and internationally as needed.
Ability to perform the physical requirements described, including occasional lifting and/or moving of up to 20 pounds, independent overnight travel, and working after hours when required by travel schedules or business needs.

Nice To Haves

Advanced degree preferred.
Experience with Veeva RIM, IQVIA SmartSolve, Lorenz Docubridge, or comparable enterprise regulatory platforms is highly valued.
Experience leading AI, machine learning, advanced analytics, knowledge management, workflow automation, structured content, or cloud-enabled regulatory submission initiatives.

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, including roadmaps, ownership, dependencies, risks, and success measures.
Advise 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 deployment, advancement, integration, validation, maintenance, training, and adoption of regulatory information and document-management capabilities, including RIM, DMS, publishing, submissions, 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 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 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 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 to technical, operational, and executive audiences.
Perform other responsibilities as assigned.

Benefits

Competitive base salary and discretionary bonus and equity awards, based on factors such as individual and organizational performance; actual amounts vary by experience, performance, and location.
Competitive base, bonus, new hire and ongoing equity packages.
Medical, dental, and vision insurance.
Employer-paid life, disability, business travel, and EAP coverage.
401(k) plan with a fully vested company match, 1:1 up to 5%.
Employee Stock Purchase Plan with a 2-year purchase price lock-in.
15+ vacation days.
13–15 paid holidays, including office closure between December 24 and January 1.
10 days of paid sick time.
Paid parental leave benefit.
Tuition assistance.