Sr. Director, Regulatory Affairs, Technology & Transformation

The role

This leader defines and executes the technology, data, training, and transformation agenda for Global Regulatory Affairs. The role modernizes regulatory processes through platforms, digitization, automation, and artificial intelligence.

What you will do

• Develop and execute Regulatory Technology and Transformation strategy
• Establish governance, prioritization, investment, and value-realization frameworks
• Serve as a trusted advisor to Regulatory and senior enterprise leaders
• Provide business leadership for deployment and adoption of regulatory information and document management capabilities
• Partner with IT, Quality, and Regulatory Operations to implement systems and manage change controls
• Lead the design, digitization, and continuous improvement of end-to-end regulatory processes
• Oversee relevant policies, SOPs, work instructions, and governance practices
• Use metrics and analytics to identify improvement opportunities
• Lead organizational change management and stakeholder engagement
• Monitor external regulatory technology trends and industry practices

Required qualifications

• Bachelor’s degree in life sciences, information systems, business, engineering, or a related field
• 12 years of progressive experience in Regulatory Affairs, Regulatory Operations, regulatory technology, or a comparable regulated life sciences function
• Significant leadership responsibility
• Success developing and executing regulatory technology, digital enablement, analytics, or enterprise transformation strategies
• Deep understanding of global regulatory processes, regulatory content development, submission management, eCTD standards, document and records management, archiving, health authority interactions, and
• 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
• Experience with organizational change management, stakeholder engagement, training, and adoption of new systems and processes
• Proven people leadership including developing teams and managing employees, contractors, consultancies, and distributed or remote resources
• Ability to travel independently overnight
• Ability to lift and/or move up to 20 pounds

Nice to have

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

Benefits

• 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 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

About the company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.