Associate Director, Regulatory Affairs Project Planning & Coordination

Acadia Pharmaceuticals Inc.•San Diego, CA

15d•$154,000 - $193,000•Hybrid

About The Position

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

Benefits

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