Associate Director, Regulatory Operations

Acadia Pharmaceuticals • San Diego, NJ

2d • 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 in electronic document management, publishing, and Regulatory Information Management systems. The Associate Director partners with Regulatory Affairs, cross-functional stakeholders, and external service providers to maintain compliant, efficient, inspection-ready processes and systems. The position works 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.

This position may be based in San Diego, California; San Francisco, California; or Princeton, New Jersey. Acadia’s hybrid model requires working in an office an average of three days per week. The role includes domestic and international travel as needed and may require overnight travel or work after hours based on 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 U.S. 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.

Responsibilities

• 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 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 to support inspection readiness.
• Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities, including registrations, submissions, archives, document metadata, records lifecycle management, dictionaries, and user administration.
• Lead and support system governance and administration, including access management, user training and experience, issue management, configuration, change control, release management, validation documentation, and operational support.
• Partner with stakeholders to translate business requirements into scalable system and process solutions.
• Ensure regulatory information, documents, and records are managed according to 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 evolving regulations, industry practices, system capabilities, artificial intelligence, automation, and emerging technologies; recommend and implement improvements and participate in industry forums and relevant conferences or events representing Acadia.
• Lead process optimization and system configuration initiatives to improve quality, compliance, efficiency, usability, and transparency.
• Develop and maintain SOPs, work instructions, standards, templates, checklists, governance documents, and training materials.
• 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.
• Perform other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Director