Senior Director, Regulatory Operations
Acadia Pharmaceuticals
11 days ago
Remote friendly (San Diego, CA)
United States
Operations
Primary Responsibilities:
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Provide strategic oversight of 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 standards.
- Evaluate, implement, and optimize regulatory systems/tools (including Veeva Vault RIM and publishing platforms) to ensure validated, compliant, scalable solutions.
- Champion digital transformation in Regulatory Affairs, including AI/advanced analytics to improve submission readiness and operational insights.
- Partner with IT/Quality/cross-functional teams to define requirements, manage validation/upgrades, and support evolving regulatory needs.
- Establish work instructions, training, and quality control for submission accuracy, consistency, and inspection readiness.
- Ensure compliance with technical standards (eCTD, CDISC, SEND) and lead adoption of best practices.
Qualifications/Experience/Skills:
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible Regulatory Operations/Regulatory Affairs experience.
- 8+ years leadership experience in electronic submissions, regulatory systems, and submission management.
- Hands-on expertise with regulatory information management and publishing systems (Veeva Vault RIM, eCTD tools).
- Experience with validated regulatory systems and understanding of the software development lifecycle.
- Willingness and ability to travel domestically and internationally.
Benefits/Compensation (as stated):
- Discretionary bonus and equity awards; salary range $220,600–$275,700 USD.
- Medical, dental, and vision insurance; 401(k) 1:1 match up to 5%; employee stock purchase plan; 15+ vacation days; paid holidays and sick time; paid parental leave; tuition assistance.
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Provide strategic oversight of 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 standards.
- Evaluate, implement, and optimize regulatory systems/tools (including Veeva Vault RIM and publishing platforms) to ensure validated, compliant, scalable solutions.
- Champion digital transformation in Regulatory Affairs, including AI/advanced analytics to improve submission readiness and operational insights.
- Partner with IT/Quality/cross-functional teams to define requirements, manage validation/upgrades, and support evolving regulatory needs.
- Establish work instructions, training, and quality control for submission accuracy, consistency, and inspection readiness.
- Ensure compliance with technical standards (eCTD, CDISC, SEND) and lead adoption of best practices.
Qualifications/Experience/Skills:
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible Regulatory Operations/Regulatory Affairs experience.
- 8+ years leadership experience in electronic submissions, regulatory systems, and submission management.
- Hands-on expertise with regulatory information management and publishing systems (Veeva Vault RIM, eCTD tools).
- Experience with validated regulatory systems and understanding of the software development lifecycle.
- Willingness and ability to travel domestically and internationally.
Benefits/Compensation (as stated):
- Discretionary bonus and equity awards; salary range $220,600–$275,700 USD.
- Medical, dental, and vision insurance; 401(k) 1:1 match up to 5%; employee stock purchase plan; 15+ vacation days; paid holidays and sick time; paid parental leave; tuition assistance.