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About the Role

The Executive Director, Regulatory Operations provides enterprise-wide strategic leadership for global regulatory operations, regulatory information management, submission technologies, and regulatory business process excellence. This senior leader defines and executes the long-term vision for regulatory operations, advances digital transformation and AI-enabled capabilities, and ensures scalable infrastructure to support Acadia's global development and commercial portfolio. The role 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.

Responsibilities

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.
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.

Requirements

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.

Location

Princeton, NJ
South San Francisco, CA
San Diego, CA

Work Type

Hybrid

Experience Level

Executive Director

Education Level

Bachelor's degree
Advanced degree preferred (MS, PharmD, PhD, MBA)

Salary/Compensations

$220,600—$275,700 USD

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 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 Parkinson’s 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 Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
At Acadia, we’re here to be their difference.

Equal Opportunity

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.