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About the Role

Provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end-to-end submission execution. This role drives operational excellence, scalability, compliance, and digital innovation across Regulatory Affairs, partnering with cross-functional teams to ensure high-quality, compliant, and timely submissions worldwide while advancing modern systems and emerging technologies, including AI.

Responsibilities

Lead and scale global Regulatory Operations, including organizational design, talent strategy, and performance management.
Provide strategic oversight of electronic submission publishing, regulatory information management, and submission management across global health authorities.
Direct worldwide eCTD and non-eCTD electronic submissions, ensuring compliance with health authority, ICH, and global regulatory standards.
Drive evaluation, implementation, and optimization of regulatory systems and tools, including Veeva Vault RIM and publishing platforms.
Champion digital transformation initiatives within Regulatory Affairs, applying AI and advanced analytics to enhance submission readiness and operational insights.
Partner with IT, Quality, and cross-functional stakeholders to define system requirements, oversee validation, manage upgrades, and support evolving regulatory needs.
Establish and maintain work instructions, training programs, and quality control processes for submission accuracy, consistency, and inspection readiness.
Ensure compliance with global regulatory technical standards, including eCTD, CDISC, and SEND, and lead adoption of evolving industry best practices.
Perform other duties as assigned.

Requirements

Ability to travel domestically and internationally.
Ability to perform regular standing, walking, sitting, and use hands for equipment operation.
Ability 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.
Ability to occasionally lift and/or move up to 20 pounds.
Ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

Skills

Expertise with regulatory information management and publishing systems (Veeva Vault RIM, eCTD tools).
Experience overseeing validated regulatory systems.
Understanding of the software development lifecycle.

Location

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

Work Type

Hybrid
Full-time

Experience Level

Minimum of 12 years of progressively responsible experience in Regulatory Operations or Regulatory Affairs.
Minimum of 8 years of leadership experience with responsibility for electronic submissions, regulatory systems, and submission management.

Education Level

Bachelor’s degree in life sciences or a related field.

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

We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. 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.
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.
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.