{"id":2945457,"url":"https://alion.io/job/acadia-pharmaceuticals-associate-director-regulatory-operations","title":"Associate Director, Regulatory Operations","company":{"id":5390,"name":"Acadia Pharmaceuticals","domain":"acadia.com","url":"https://alion.io/company/acadia-pharmaceuticals-inc","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Princeton, United States","San Diego, United States","South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":146000,"max":182500,"currency":"USD","period":"year","gross":null,"usd_annual":182500},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-10-20T17:55:39Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-11-04T17:35:53Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"About Acadia Pharmaceuticals\nAcadia 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.\nPlease 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.\nPosition Summary\nThe 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.\nPrimary Responsibilities\nRegulatory Submission Operations\nLead and oversee the planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence\nCoordinate submission deliverables for applications and lifecycle activities, including INDs, CTAs, NDAs, MAAs, amendments, supplements, health authority responses, and briefing documents\nProvide tactical guidance to global regulatory teams, translate regulatory strategy into executable operational plans, and identify and mitigate submission risks\nInterpret and apply current electronic submission standards, health authority technical requirements, internal policies, and operating procedures\nServe as a point of escalation for submission, publishing, document, process, and technology issues; drive timely resolution with internal teams, IT and vendors\nMaintain complete, traceable, accurate, and readily retrievable regulatory records to support inspection readiness\nRegulatory Information and Document Management\nProvide 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\nLead 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\nPartner with stakeholders to gather and translate business requirements into scalable system and process solutions\nEnsure regulatory information, documents, and records are managed in accordance with applicable regulations, company procedures, and validated-system requirements\nTechnology, Validation, and Continuous Improvement\nPartner with Information Technology, Quality, other business owners, and vendors on system implementations, upgrades, integrations, validation, and operational support\nSupport validation activities, including user needs, requirements, risk assessment, test planning, test script authoring and execution, defect resolution, and release readiness\nEvaluate 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\nLead process optimization and system configuration initiatives that improve quality, compliance, efficiency, usability, and transparency\nDevelop and maintain SOPs, work instructions, standards, templates, checklists, governance documents, and training materials\nBusiness Partnership\nAct as a trusted Regulatory Operations advisor to global regulatory teams and cross-functional partners\nLead cross-functional initiatives and taskforces; influence decisions and promote consistent global practices without relying on formal authority\nOversee external vendors, consultants, and contractors, including scope, quality, timelines, performance, and budget responsibilities\nMay oversee and develop junior personnel and project team members, as assigned\nOther responsibilities as assigned\nEducation/Experience/Skills\nBachelor’s degree in scientific discipline or related field. An equivalent combination of relevant education and experience may be considered\nTargeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry\nMust have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools\nMust have technical expertise in EDMS oversight\nThorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations\nAbility to influence and partner cross-functionally\nSelf-organized, self-directing, and highly motivated\nStrong critical thinking and analytical skills\nDemonstrated ability to contribute to a continuous learning and process improvement environment\nExcellent verbal and written organizational and communication skills\nWillingness and ability to travel domestically and internationally as needed\nPhysical Requirements\nThis 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.\n#LI-RE1 #LI-HYBRID\nIn 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. \nSalary Range\n$146,000—$182,500 USD\nWhat we offer US-based Employees:\nCompetitive base, bonus, new hire and ongoing equity packages\nMedical, dental, and vision insurance\nEmployer-paid life, disability, business travel and EAP coverage\n401(k) Plan with a fully vested company match 1:1 up to 5%\nEmployee Stock Purchase Plan with a 2-year purchase price lock-in\n15+ vacation days\n13 -15 paid holidays, including office closure between December 24th and January 1st\n10 days of paid sick time\nPaid parental leave benefit\nTuition assistance\nEEO 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 strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.\nIt 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.\nAs 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  or 858-261-2923.\nPlease 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.\nCalifornia Applicants: Please see Additional Information for California Residents within our Privacy Policy. \nCanadian Applicants: Please seeAdditional Information for Canadian Residents withinour Privacy Policy. \nApplicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy. \nNotice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.","description_format":"text","description_chars":10734,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity","Parental leave","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"New Jersey","iso":null,"kind":"city"},{"name":"California","iso":null,"kind":"city"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Prescription Drugs","Neurology & CNS Therapeutics","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T18:36:15Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":14,"expected_fill_days":54,"reasons":["conf:3","win:early"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":182500,"is_top_pay":false},"html_url":"https://alion.io/job/acadia-pharmaceuticals-associate-director-regulatory-operations","json_url":"https://alion.io/job/acadia-pharmaceuticals-associate-director-regulatory-operations.json","meta":{"generated_at":"2026-11-04T19:34:01Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":30116,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5390},"rest":"https://alion.io/mcp/rest/get_company?id=5390"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Facadia-pharmaceuticals-associate-director-regulatory-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Facadia-pharmaceuticals-associate-director-regulatory-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Facadia-pharmaceuticals-associate-director-regulatory-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/acadia-pharmaceuticals-associate-director-regulatory-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Facadia-pharmaceuticals-associate-director-regulatory-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2945457}},{"tool":"search_jobs","arguments":{"company":"acadia.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2945457},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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