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 need