Senior Director, Regulatory Operations

• Lead and scale the global Regulatory Operations function, including organizational design, talent strategy, and performance management aligned to business and regulatory objectives
• Provide strategic oversight of electronic submission publishing, regulatory information management, and submission management across global health authorities
• Direct worldwide eCTD and non‑eCTD electronic submissions to ensure compliance with health authority, ICH, and global regulatory standards
• Drive evaluation, implementation, and optimization of regulatory systems and tools, including Veeva Vault RIM and publishing platforms, ensuring validated, compliant, and scalable solutions
• Champion digital transformation initiatives within Regulatory Affairs, including the application of AI and advanced analytics to enhance submission readiness and operational insights
• Partner with IT, Quality, and cross‑functional stakeholders to define system requirements, oversee validation, manage upgrades, and support evolving regulatory needs
• Establish and maintain work instructions, training programs, and quality control processes to ensure submission accuracy, consistency, and inspection readiness
• Ensure compliance with global regulatory technical standards, including eCTD, CDISC, and SEND, and lead adoption of evolving industry best practices
• Other duties as assigned

Education/Experience/Skills

• Bachelor’s degree in life sciences or a related field
• Minimum of 12 years of progressively responsible experience in Regulatory Operations or Regulatory Affairs
• Minimum of 8 years of leadership experience with responsibility for electronic submissions, regulatory systems, and submission management
• Hands‑on expertise with regulatory information management and publishing systems, including Veeva Vault RIM and eCTD tools
• Experience overseeing validated regulatory systems and understanding of the software development lifecycle
• Willingness and ability to travel domestically and internationally

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. #LI-CS1

#LI-HYBRID

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. 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. It 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. 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 talentacquisition@acadia-pharm.com or 858-261-2923. Please 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. California Applicants: Please see Additional Information for California Residents within our Privacy Policy. Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy. Applicants 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. Notice 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.