Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
14 hours ago
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Position Summary
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices for the Global Regulatory Affairs team. Leads planning of regulatory submission timelines, compliance/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 Health Authority commitment tracker across pre- and post-approval portfolio.
- Coordinate governance processes and the cadence of regulatory strategy reviews/endorsements with Global Regulatory Affairs Leadership.
- Design, implement, and maintain regulatory dashboards and scorecards for visibility, risk identification, and proactive planning.
- Develop/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 deliverables vs. development/corporate objectives.
- 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.
- Domestic and international travel willingness/ability.
Compensation & Benefits
- Salary range: $154,000–$193,000 USD.
- Eligible for discretionary bonus and equity awards.
- Medical, dental, vision; 401(k) match (1:1 up to 5%); ESPP; 15+ vacation days; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance.
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices for the Global Regulatory Affairs team. Leads planning of regulatory submission timelines, compliance/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 Health Authority commitment tracker across pre- and post-approval portfolio.
- Coordinate governance processes and the cadence of regulatory strategy reviews/endorsements with Global Regulatory Affairs Leadership.
- Design, implement, and maintain regulatory dashboards and scorecards for visibility, risk identification, and proactive planning.
- Develop/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 deliverables vs. development/corporate objectives.
- 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.
- Domestic and international travel willingness/ability.
Compensation & Benefits
- Salary range: $154,000–$193,000 USD.
- Eligible for discretionary bonus and equity awards.
- Medical, dental, vision; 401(k) match (1:1 up to 5%); ESPP; 15+ vacation days; 13–15 paid holidays; paid sick time; paid parental leave; tuition assistance.