Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
August 17, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
The Associate Director, Regulatory Affairs Project Planning & Coordination develops, implements, and monitors project plans and best practices that enable the Global Regulatory Affairs department to execute its strategic and functional goals.
Primary Responsibilities
- Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
- Establish and oversee a Health Authority commitment tracker across pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with leadership
- Design, implement, and maintain regulatory dashboards/scorecards for visibility, risk identification, and proactive planning
- Develop and manage a clinical trial public disclosure tracker and lead periodic cross-functional status reviews
- Support meeting planning, materials, and bi-annual in-person meeting coordination
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation/maintenance/review of documentation for regulatory development and marketing applications, including SOP review
Education/Experience/Skills
- Bachelor’s degree in life science, healthcare, or related field
- 8+ years regulatory drug development experience (pharma or related industry)
- Experience supporting global regulatory submissions and health authority interactions
- Willingness/ability to travel domestically and internationally
Benefits (US-based employees)
- Competitive base plus discretionary bonus and equity; medical/dental/vision; 401(k) match (1:1 up to 5%); stock purchase plan; 15+ vacation days; paid holidays and sick time; paid parental leave; tuition assistance.
The Associate Director, Regulatory Affairs Project Planning & Coordination develops, implements, and monitors project plans and best practices that enable the Global Regulatory Affairs department to execute its strategic and functional goals.
Primary Responsibilities
- Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
- Establish and oversee a Health Authority commitment tracker across pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with leadership
- Design, implement, and maintain regulatory dashboards/scorecards for visibility, risk identification, and proactive planning
- Develop and manage a clinical trial public disclosure tracker and lead periodic cross-functional status reviews
- Support meeting planning, materials, and bi-annual in-person meeting coordination
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation/maintenance/review of documentation for regulatory development and marketing applications, including SOP review
Education/Experience/Skills
- Bachelor’s degree in life science, healthcare, or related field
- 8+ years regulatory drug development experience (pharma or related industry)
- Experience supporting global regulatory submissions and health authority interactions
- Willingness/ability to travel domestically and internationally
Benefits (US-based employees)
- Competitive base plus discretionary bonus and equity; medical/dental/vision; 401(k) match (1:1 up to 5%); stock purchase plan; 15+ vacation days; paid holidays and sick time; paid parental leave; tuition assistance.