Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
August 15, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Position Summary:
The Associate Director, Regulatory Affairs Project Planning & Coordination develops, implements, and monitors project plans and best practices for the Global Regulatory Affairs department. Plans include regulatory submission timelines, compliance and maintenance activities, and department conduct.
Primary 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 pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with Global Regulatory Affairs Leadership
- Design, implement, and maintain regulatory dashboards and 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 for leadership and regulatory project teams
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation, maintenance, and review of documentation for regulatory development and marketing applications, including SOP review
- Other duties as assigned
Education/Experience/Skills:
- Bachelor’s degree in life science, healthcare, or related field
- Minimum 8 years of regulatory drug development experience in pharma or related industry
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits/Compensation (as stated):
- Discretionary bonus and equity awards eligible; Salary range: $154,000–$193,000 USD
- Medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance
The Associate Director, Regulatory Affairs Project Planning & Coordination develops, implements, and monitors project plans and best practices for the Global Regulatory Affairs department. Plans include regulatory submission timelines, compliance and maintenance activities, and department conduct.
Primary 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 pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with Global Regulatory Affairs Leadership
- Design, implement, and maintain regulatory dashboards and 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 for leadership and regulatory project teams
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation, maintenance, and review of documentation for regulatory development and marketing applications, including SOP review
- Other duties as assigned
Education/Experience/Skills:
- Bachelor’s degree in life science, healthcare, or related field
- Minimum 8 years of regulatory drug development experience in pharma or related industry
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits/Compensation (as stated):
- Discretionary bonus and equity awards eligible; Salary range: $154,000–$193,000 USD
- Medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance