Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
August 16, 2026
Remote friendly (San Diego, CA)
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 Global Regulatory Affairs to execute strategic and functional goals. Manages 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 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 for regulatory alignment and track deliverables vs. development and corporate objectives.
- Support preparation, maintenance, and review of documentation for regulatory development and marketing applications, including SOP review.
- Other duties as assigned.
Qualifications
- Bachelor’s degree in life science, healthcare, or related field.
- Minimum 8 years of regulatory drug development experience in pharma/related industry.
- Demonstrated experience with global regulatory submissions and health authority interactions.
- Willingness and ability to travel domestically and internationally.
Compensation & Benefits (select)
- Eligible for discretionary bonus and equity awards.
- Salary range: $154,000—$193,000 USD.
- Medical, dental, vision; 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan; 15+ vacation days; paid holidays; 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 Global Regulatory Affairs to execute strategic and functional goals. Manages 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 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 for regulatory alignment and track deliverables vs. development and corporate objectives.
- Support preparation, maintenance, and review of documentation for regulatory development and marketing applications, including SOP review.
- Other duties as assigned.
Qualifications
- Bachelor’s degree in life science, healthcare, or related field.
- Minimum 8 years of regulatory drug development experience in pharma/related industry.
- Demonstrated experience with global regulatory submissions and health authority interactions.
- Willingness and ability to travel domestically and internationally.
Compensation & Benefits (select)
- Eligible for discretionary bonus and equity awards.
- Salary range: $154,000—$193,000 USD.
- Medical, dental, vision; 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan; 15+ vacation days; paid holidays; sick time; paid parental leave; tuition assistance.