Senior Director, Regulatory Operations
Acadia Pharmaceuticals
11 days ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
- Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end-to-end submission execution. Partners with Regulatory Affairs leadership, IT, Quality, and cross-functional teams to ensure high-quality, compliant, timely submissions worldwide while advancing modern systems and technologies (including AI).
Primary Responsibilities
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Oversee electronic submission publishing, regulatory information management, and submission management across global health authorities.
- Direct worldwide eCTD and non-eCTD electronic submissions to ensure compliance with health authority, ICH, and global regulatory standards.
- Evaluate, implement, and optimize regulatory systems/tools (e.g., Veeva Vault RIM and publishing platforms) for validated, compliant, scalable solutions.
- Champion digital transformation (AI and advanced analytics) to improve submission readiness and operational insights.
- Partner with IT/Quality to define requirements, manage validation, upgrades, and evolving regulatory needs.
- Establish/maintain work instructions, training, and quality control for submission accuracy, consistency, and inspection readiness.
- Ensure compliance with eCTD, CDISC, and SEND technical standards and adopt best practices.
Education/Experience/Skills
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible experience in Regulatory Operations or Regulatory Affairs.
- 8+ years leadership experience for electronic submissions, regulatory systems, and submission management.
- Hands-on regulatory information management/publishing systems (including Veeva Vault RIM and eCTD tools).
- Experience overseeing validated regulatory systems and understanding of the software development lifecycle.
- Ability to travel domestically and internationally.
- Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end-to-end submission execution. Partners with Regulatory Affairs leadership, IT, Quality, and cross-functional teams to ensure high-quality, compliant, timely submissions worldwide while advancing modern systems and technologies (including AI).
Primary Responsibilities
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Oversee electronic submission publishing, regulatory information management, and submission management across global health authorities.
- Direct worldwide eCTD and non-eCTD electronic submissions to ensure compliance with health authority, ICH, and global regulatory standards.
- Evaluate, implement, and optimize regulatory systems/tools (e.g., Veeva Vault RIM and publishing platforms) for validated, compliant, scalable solutions.
- Champion digital transformation (AI and advanced analytics) to improve submission readiness and operational insights.
- Partner with IT/Quality to define requirements, manage validation, upgrades, and evolving regulatory needs.
- Establish/maintain work instructions, training, and quality control for submission accuracy, consistency, and inspection readiness.
- Ensure compliance with eCTD, CDISC, and SEND technical standards and adopt best practices.
Education/Experience/Skills
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible experience in Regulatory Operations or Regulatory Affairs.
- 8+ years leadership experience for electronic submissions, regulatory systems, and submission management.
- Hands-on regulatory information management/publishing systems (including Veeva Vault RIM and eCTD tools).
- Experience overseeing validated regulatory systems and understanding of the software development lifecycle.
- Ability to travel domestically and internationally.