Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
17 days ago
Remote friendly (San Francisco, 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 that enable Global Regulatory Affairs to execute its strategic and functional goals. Plans and timelines support regulatory submissions, 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 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 to objectives
- 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 (pharma or related)
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness/ability to travel domestically and internationally
Compensation/Benefits (as stated)
- Salary range: $154,000–$193,000 USD
- Eligible for discretionary bonus and equity awards
- Medical, dental, vision; employer-paid life/disability/travel/EAP; 401(k) 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days 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 that enable Global Regulatory Affairs to execute its strategic and functional goals. Plans and timelines support regulatory submissions, 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 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 to objectives
- 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 (pharma or related)
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness/ability to travel domestically and internationally
Compensation/Benefits (as stated)
- Salary range: $154,000–$193,000 USD
- Eligible for discretionary bonus and equity awards
- Medical, dental, vision; employer-paid life/disability/travel/EAP; 401(k) 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance