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Execuitve Director, Regulatory Operations

Acadia Pharmaceuticals

Job Location:

San Diego, CA - USA

Monthly Salary: Not provided by the employer

Posted: 29 May 2026 (30+ days ago)

Application Deadline: 6 November 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinsons disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimers disease psychosis and Lewy body dementia psychosis along with earlier-stage programs that address other underserved patient needs. At Acadia were here to be their difference.

Please note that this position is based in Princeton NJ South San Francisco CA or San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

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 Acadias 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.

Primary Responsibilities

Develop and execute the global Regulatory Operations strategy aligned with Acadias 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.
Other duties as assigned

Education/Experience/Skills

Bachelors 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.

Physical Requirements

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.

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Required Experience:

Director

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