Associate Director, Regulatory Operations

Acadia Pharmaceuticals Inc.•San Diego, CA

2d•$146,000 - $182,500•Hybrid

About The Position

The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document management, and related technology. The role leads submission planning and delivery for assigned development and marketed products and serves as a subject matter expert for electronic document management, publishing, and Regulatory Information Management systems. It partners with Regulatory Affairs, cross-functional stakeholders, and external service providers to maintain compliant, efficient, and inspection-ready processes and systems. The position operates independently, resolves complex operational and technical issues, and drives continuous improvement through governance, metrics, data quality, automation, and emerging technology. The role may be based in San Diego, San Francisco, or Princeton and follows a hybrid model requiring an average of three days per week in the office. It may include domestic and international travel, occasional overnight travel, and work after hours as required by travel schedules or business needs.

Requirements

Bachelor’s degree in a 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.
Strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools.
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.
Ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
Ability to perform regular standing, walking, sitting, and hand use for handling or operating equipment; occasional reaching, climbing, balancing, stooping, kneeling, crouching, and visual, verbal, and auditory communication; and occasional lifting or moving of up to 20 pounds.

Responsibilities

Lead planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence.
Coordinate 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 operational plans, and identify and mitigate submission risks.
Interpret and apply electronic submission standards, health authority technical requirements, internal policies, and operating procedures.
Escalate and resolve submission, publishing, document, process, and technology issues with internal teams, IT, and vendors.
Maintain complete, traceable, accurate, and readily retrievable regulatory records for inspection readiness.
Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities, including registrations, submissions, archives, metadata, records lifecycle management, dictionaries, and user administration.
Lead system governance and administration, including access management, training and user experience, issue management, configuration, change control, release management, validation documentation, and operational support.
Translate stakeholder business requirements into scalable system and process solutions.
Ensure regulatory information, documents, and records comply with applicable regulations, company procedures, and validated-system requirements.
Partner with IT, Quality, 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 regulations, industry practices, system capabilities, AI, automation, and emerging technologies; recommend and implement improvements and participate in industry forums and relevant conferences or 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.
Advise global regulatory teams and cross-functional partners on Regulatory Operations.
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.
Perform other responsibilities as assigned.

Benefits

Competitive base salary and discretionary bonus and equity awards, with amounts varying by experience, performance, and location.
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 of 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 24 and January 1.
10 days of paid sick time.
Paid parental leave benefit.
Tuition assistance.