Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
11 hours ago
Remote friendly (San Diego, CA)
United States
Corporate Functions
Position Summary
The Associate Director, Regulatory Affairs Project Planning & Coordination develops, implements, and monitors project plans and best practices to support Global Regulatory Affairs’ strategic and functional goals. Plans 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 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 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
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation, maintenance, and review of regulatory development and marketing application documentation, 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
- Experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits (US-based Employees)
- Competitive base, bonus, and new hire/ongoing equity packages; medical/dental/vision; employer-paid life/disability/business travel/EAP; 401(k) match 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 develops, implements, and monitors project plans and best practices to support Global Regulatory Affairs’ strategic and functional goals. Plans 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 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 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
- Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables
- Support preparation, maintenance, and review of regulatory development and marketing application documentation, 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
- Experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits (US-based Employees)
- Competitive base, bonus, and new hire/ongoing equity packages; medical/dental/vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance