Associate Director, Regulatory Affairs Project Planning & Coordination

Acadia Pharmaceuticals • San Diego, NJ

83d • Hybrid

About The Position

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 can be based in San Diego, CA, San Francisco, CA or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. This role will create best practices that maximize the efficiency and impact in which Global Regulatory Affairs develops, endorses, and executes regulatory strategy. This role will also be involved in planning of regulatory submission timelines, compliance and maintenance activities, and department conduct.

Requirements

• Bachelor’s degree in life science, healthcare, or related field.
• Minimum of 8 years of regulatory drug development experience within the pharmaceutical or related industry
• Demonstrated experience supporting global regulatory submissions and health authority interactions
• Willingness and ability to travel domestically and internationally

Responsibilities

• Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
• Establish and oversee a comprehensive Health Authority commitment tracker across Acadia’s pre‑ and post‑approval portfolio
• Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with the Global Regulatory Affairs Leadership Team
• Design, implement, and maintain regulatory dashboards and scorecards to enable visibility, risk identification, and proactive planning
• Develop and manage a clinical trial public disclosure tracker and lead periodic cross‑functional status reviews
• Support Global Regulatory Affairs Leadership Team and Regulatory Project Teams with meeting planning, materials, and bi‑annual in‑person meeting coordination
• Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables against development and corporate objectives
• Support the preparation, maintenance, and review of documentation supporting regulatory development and marketing applications, including SOP review
• Other duties as assigned

What This Job Offers

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