About Acadia Pharmaceuticals
Acadia 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.
Please note that this position is based in Princeton, NJ, South San Francisco, CA or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary
The Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end‑to‑end submission execution. This role is a key member of the Global Regulatory Affairs Leadership Team and plays a critical role in driving operational excellence, scalability, compliance, and digital innovation across Regulatory Affairs. The position partners closely with Regulatory Affairs leadership, IT, Quality, and cross‑functional teams to ensure high‑quality, compliant, and timely submissions worldwide while advancing modern systems and emerging technologies, including AI.
Primary Responsibilities
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.
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