Senior Director, Regulatory Technology & Transformation

Acadia Pharmaceuticals; Princeton (NJ); Hybrid; USD 221,000 - 276,000; Full time

Benefits offered by this job

Medical insurance

Dental & vision

401k matching

Employee stock purchase

Vacation days

Paid holidays

Parental leave

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Senior Director, Regulatory Affairs, Technology & Transformation to lead regulatory tech strategy and transformation across Global Regulatory Affairs. This role modernizes processes via AI, analytics, digitization, and structured content to improve quality, speed, and inspection readiness.

The position collaborates with IT, Quality, and business stakeholders to implement systems, manage upgrades, and enable scalable, compliant solutions in a hybrid work environment.

Qualifications

• Bachelor's degree in life sciences, information systems, business, engineering or related field.
• Targeting 12 years of progressive experience in Regulatory Affairs or regulatory technology.
• Proven success delivering regulatory technology, digital enablement and analytics strategies.
• Deep understanding of global regulatory processes and submission management.
• Experience with regulatory information management and document management platforms.
• Strong leadership and change-management capabilities across global teams.

Responsibilities

• Develop and execute Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs objectives.
• Establish governance, prioritization, investment, and value-realization frameworks for tech initiatives.
• Serve as advisor on AI, analytics, automation, and digital authoring opportunities.
• Lead deployment, validation, maintenance, and adoption of regulatory information and document management tools.
• Partner with IT and Quality to define user requirements and manage upgrades and change controls.
• Advance interoperable regulatory data/capabilities across enterprise systems.
• Lead end-to-end regulatory process redesign to reduce risk and improve speed and quality.

Skills

Regulatory technology

AI in regulatory

Regulatory operations leadership

Communication skills

Change management

GxP knowledge

Education

Bachelor's degree in life sciences, information systems, business, engineering

Tools

Veeva RIM

IQVIA SmartSolve

Lorenz Docubridge

Job description

Acadia Pharmaceuticals seeks a Senior Director, Regulatory Affairs, Technology & Transformation to lead regulatory tech strategy and transformation across Global Regulatory Affairs. This role modernizes processes via AI, analytics, digitization, and structured content to improve quality, speed, and inspection readiness.

The position collaborates with IT, Quality, and business stakeholders to implement systems, manage upgrades, and enable scalable, compliant solutions in a hybrid work environment.