Sr. Director, Regulatory Affairs, Technology & Transformation

Acadia Pharmaceuticals•San Diego, NJ

2d•Hybrid

About The Position

The Sr. Director, Regulatory Affairs, Technology & Transformation is a strategic leader within Regulatory Operations who defines and executes the technology, data, training, and transformation agenda for Global Regulatory Affairs. The role modernizes regulatory capabilities through fit-for-purpose platforms, digitization, automation, analytics, artificial intelligence, structured content, and new ways of working. It connects business strategy with operational execution and ensures solutions are compliant, scalable, adopted, and focused on measurable improvements in quality, speed, transparency, and organizational effectiveness. The role may be based in San Diego or San Francisco, California, or Princeton, New Jersey. Acadia’s hybrid model requires working in an office an average of three days per week. Domestic and international travel may be needed. The position includes work in a standard office environment and may also involve working independently from remote locations.

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.
Demonstrated experience with organizational change management, stakeholder engagement, training, and adoption of new systems and processes across global, cross-functional organizations.
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 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 travel independently overnight and/or work after hours as required by travel schedules or business needs.
Ability to perform the physical requirements of the role, including occasional lifting and/or moving of up to 20 pounds.

Nice To Haves

An advanced degree.
Experience with Veeva RIM, IQVIA SmartSolve, Lorenz Docubridge, or comparable enterprise regulatory platforms.
Active engagement in regulatory operations, technology, and industry forums, with a strong external network and awareness of emerging practices.
Experience leading AI, machine learning, advanced analytics, knowledge management, workflow automation, structured content, or cloud-enabled regulatory submission initiatives.

Responsibilities

Develop and execute a Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs objectives, corporate priorities, 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.
Lead business 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 support 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 to reduce 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 to embed new capabilities and ways of working.
Foster innovation, continuous learning, disciplined experimentation, and accountability while grounding innovation in business needs and compliance expectations.
Monitor 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.
Carry out other responsibilities as assigned.
Travel domestically and internationally as needed; travel schedules or business needs may require overnight travel or after-hours work.