Associate Director, Regulatory Operations

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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Pay and benefits

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.

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