Senior Director, Regulatory Operations
Acadia Pharmaceuticals
10 days ago
Remote friendly (Princeton, NJ)
United States
Operations
Responsibilities:
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Oversee electronic submission publishing, regulatory information management, and submission management across health authorities.
- Direct worldwide eCTD and non-eCTD submissions to ensure compliance with health authority, ICH, and global standards.
- Evaluate/implement/optimize regulatory systems and tools (e.g., Veeva Vault RIM and publishing platforms) to ensure validated, compliant, scalable solutions.
- Drive regulatory digital transformation, using AI and advanced analytics to improve readiness and operational insights.
- Partner with IT and Quality to define system requirements, oversee validation, manage upgrades, and support evolving needs.
- Establish work instructions, training, and quality control processes to ensure accuracy, consistency, and inspection readiness.
- Ensure compliance with technical standards (eCTD, CDISC, SEND) and adopt evolving industry best practices.
Qualifications:
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible Regulatory Operations/Affairs experience.
- 8+ years leadership experience covering electronic submissions, regulatory systems, and submission management.
- Hands-on experience with regulatory information management/publishing systems (Veeva Vault RIM, eCTD tools).
- Experience overseeing validated regulatory systems; understanding of software development lifecycle.
- Ability to travel domestically/internationally.
Benefits (highlights): Medical/dental/vision; employer-paid life/disability/EAP/business travel; 401(k) match up to 5%; paid vacation/holidays/sick time; paid parental leave; tuition assistance.
- Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management).
- Oversee electronic submission publishing, regulatory information management, and submission management across health authorities.
- Direct worldwide eCTD and non-eCTD submissions to ensure compliance with health authority, ICH, and global standards.
- Evaluate/implement/optimize regulatory systems and tools (e.g., Veeva Vault RIM and publishing platforms) to ensure validated, compliant, scalable solutions.
- Drive regulatory digital transformation, using AI and advanced analytics to improve readiness and operational insights.
- Partner with IT and Quality to define system requirements, oversee validation, manage upgrades, and support evolving needs.
- Establish work instructions, training, and quality control processes to ensure accuracy, consistency, and inspection readiness.
- Ensure compliance with technical standards (eCTD, CDISC, SEND) and adopt evolving industry best practices.
Qualifications:
- Bachelor’s degree in life sciences or related field.
- 12+ years progressively responsible Regulatory Operations/Affairs experience.
- 8+ years leadership experience covering electronic submissions, regulatory systems, and submission management.
- Hands-on experience with regulatory information management/publishing systems (Veeva Vault RIM, eCTD tools).
- Experience overseeing validated regulatory systems; understanding of software development lifecycle.
- Ability to travel domestically/internationally.
Benefits (highlights): Medical/dental/vision; employer-paid life/disability/EAP/business travel; 401(k) match up to 5%; paid vacation/holidays/sick time; paid parental leave; tuition assistance.