Executive Director, Regulatory Operations

The Executive Director, Regulatory Operations provides enterprise-wide strategic leadership for global regulatory operations, regulatory information management, submission technologies, and regulatory business process excellence. As a senior leader within Global Regulatory Affairs, this role is responsible for defining and executing the long-term vision for regulatory operations, advancing digital transformation and AI-enabled capabilities, and ensuring scalable infrastructure to support Acadia's global development and commercial portfolio.

The Executive Director serves as a key strategic partner to executive leadership across Regulatory Affairs, IT, Quality, Development, and Commercial organizations to drive operational excellence, compliance, inspection readiness, and organizational effectiveness.

Develop and execute the global Regulatory Operations strategy aligned with Acadia's corporate and portfolio objectives.

Serve as a senior member of the Global Regulatory Affairs leadership team, influencing cross-functional and enterprise-wide strategic decisions.

Lead global regulatory operations, regulatory technology, and information management capabilities across development and commercial programs.

Establish long-term roadmaps for regulatory systems, automation, AI, data governance, and digital innovation.

Represent Regulatory Operations in executive governance forums and strategic planning discussions.

Drive organizational design, succession planning, leadership development, and talent strategies for a high-performing global Regulatory Operations organization.

Provide executive oversight for health authority submission readiness, inspection preparedness, and regulatory compliance activities.

Build and maintain relationships with key external partners, vendors, industry groups, and regulatory agencies as appropriate.

Lead due diligence and integration activities related to business development, partnerships, acquisitions, and portfolio expansion.

Oversee regulatory operations budgets, resource planning, vendor strategy, and investment prioritization.

Bachelor's degree in life sciences or related field; advanced degree preferred (MS, PharmD, PhD, MBA).

Minimum 15+ years of progressively responsible experience in Regulatory Operations, Regulatory Affairs, or related functions.

Minimum 12+ years of people leadership experience, including leadership of leaders and global teams.

Demonstrated experience shaping global regulatory operations strategy for late-stage development and commercial products.

Proven track record leading large-scale digital transformation, regulatory technology, and process optimization initiatives.

Experience presenting to executive leadership and influencing enterprise-level decisions.

Strong understanding of global regulatory frameworks, health authority requirements, and industry trends.

Experience managing significant budgets, vendor partnerships, and global operating models.

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations.

The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.