Associate Director, Regulatory Operations

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 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.

Please note that this position can be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document management, and related technology. This role leads regulatory submission planning and delivery for assigned development and marketed products, serves as a subject matter expert for electronic document management, publishing, and Regulatory Information Management systems. The Associate Director partners with Regulatory Affairs and other cross-functional stakeholders, including external service providers to maintain compliant, efficient, inspection-ready processes and systems. The position operates with a high degree of independence, resolves complex operational and technical issues, and drives continuous improvement through governance, metrics, data quality, automation, and emerging technology.

Primary Responsibilities

Regulatory Submission Operations

Lead and oversee the planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence

Coordinate submission deliverables for applications and lifecycle activities, including INDs, CTAs, NDAs, MAAs, amendments, supplements, health authority responses, and briefing documents

Provide tactical guidance to global regulatory teams, translate regulatory strategy into executable operational plans, and identify and mitigate submission risks

Interpret and apply current electronic submission standards, health authority technical requirements, internal policies, and operating procedures

Serve as a point of escalation for submission, publishing, document, process, and technology issues; drive timely resolution with internal teams, IT and vendors

Maintain complete, traceable, accurate, and readily retrievable regulatory records to support inspection readiness

Regulatory Information and Document Management

Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities, including registrations, submissions, submission archives, document metadata, records lifecycle management, dictionaries, and user administration

Lead and support system governance and administrative processes, including access management, user training and experience, issue management, configuration, change control, release management, validation documentation, and ongoing operational support

Partner with stakeholders to gather and translate business requirements into scalable system and process solutions

Ensure regulatory information, documents, and records are managed in accordance with applicable regulations, company procedures, and validated-system requirements

Technology, Validation, and Continuous Improvement

Partner with Information Technology, Quality, other business owners, and vendors on system implementations, upgrades, integrations, validation, and operational support

Support validation activities, including user needs, requirements, risk assessment, test planning, test script authoring and execution, defect resolution, and release readiness

Evaluate evolving regulations, industry practices, system capabilities, artificial intelligence, automation, and emerging technologies; recommend and implement fit-for-purpose improvements and participate in industry forums and represent Acadia at relevant conferences/events

Lead process optimization and system configuration initiatives that improve quality, compliance, efficiency, usability, and transparency

Develop and maintain SOPs, work instructions, standards, templates, checklists, governance documents, and training materials

Business Partnership

Act as a trusted Regulatory Operations advisor to global regulatory teams and cross-functional partners

Lead cross-functional initiatives and taskforces; influence decisions and promote consistent global practices without relying on formal authority

Oversee external vendors, consultants, and contractors, including scope, quality, timelines, performance, and budget responsibilities

May oversee and develop junior personnel and project team members, as assigned

Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in scientific discipline or related field. An equivalent combination of relevant education and experience may be considered

Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry

Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools

Must have technical expertise in EDMS oversight

Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations

Ability to influence and partner cross-functionally

Self-organized, self-directing, and highly motivated

Strong critical thinking and analytical skills

Demonstrated ability to contribute to a continuous learning and process improvement environment

Excellent verbal and written organizational and communication skills

Willingness and ability to travel domestically and internationally as needed

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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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$146,000 — $182,500 USD

What we offer US-based Employees:

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

EEO Statement (US-based Employees): 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