Regulatory Tech & Transformation Director

Acadia Pharmaceuticals; San Diego (CA); Hybrid; USD 221,000 - 276,000; Full time

Benefits offered by this job

Discretionary bonus

Equity awards

Medical, dental, and vision insurance

401(k) Plan with company match

Job summary

Acadia Pharmaceuticals is seeking a Sr. Director of Regulatory Affairs, Technology & Transformation to lead Regulatory Operations innovation. The role focuses on modernizing processes through AI, automation, structured content, and digitization, delivering measurable improvements in quality, speed, and transparency.

The position supports global regulatory platforms, governance, and change management across regions, with a hybrid in-office model and travel as needed.

Qualifications

• Bachelor’s or higher in life sciences, information systems, business, engineering, or related field.
• Targeting 12+ years in Regulatory Affairs, Regulatory Operations, or regulatory technology with leadership responsibility.
• Proven success delivering regulatory tech, analytics, or enterprise transformation strategies.
• Deep understanding of global regulatory processes, eCTD standards, and submission management.
• Experience with regulatory information management and document management platforms (Veeva RIM, IQVIA SmartSolve).
• Strong ability to translate strategy into practical execution and measurable outcomes.

Responsibilities

• Develop and drive Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs.
• Establish governance, roadmaps, and value realization frameworks for tech initiatives.
• Advise regulatory and senior leaders on capabilities, AI, automation, and structured content.
• Oversee deployment, adoption, and governance of regulatory information management and document management tools.
• Collaborate with IT, Quality, and business stakeholders to implement compliant, scalable systems.
• Lead organizational change management and stakeholder communications for new capabilities.

Skills

Regulatory Tech

Leadership

AI & Analytics

Regulatory Operations

Education

Life sciences degree

Advanced degree preferred

Tools

Veeva RIM

IQVIA SmartSolve

Lorenz Docubridge

Job description

Acadia Pharmaceuticals is seeking a Sr. Director of Regulatory Affairs, Technology & Transformation to lead Regulatory Operations innovation. The role focuses on modernizing processes through AI, automation, structured content, and digitization, delivering measurable improvements in quality, speed, and transparency.

The position supports global regulatory platforms, governance, and change management across regions, with a hybrid in-office model and travel as needed.