Regulatory Systems Leader - Veeva RIM & Ops

Regulatory Jobs; South San Francisco (CA); Hybrid; USD 181,000 - 211,000; Full time

Job summary

Cytokinetics, a cardiovascular biopharmaceutical company, seeks a Sr. Manager Regulatory Operations – Systems to lead regulatory systems management and improvements, focusing on Veeva Vault RIM.

The role partners with QA, IT, and Regulatory teams to maintain configuration, roles, and access while driving adoption of enhancements. You will contribute to the global regulatory submission process, assist with system upgrades, and participate in validation activities, cross-training across Regulatory

Qualifications

• Bachelor’s degree required with 5+ years managing regulatory operations systems or regulatory publishing.
• Strong understanding of Veeva RIM, supporting/maintaining regulatory operations systems, and global regulatory submission requirements.
• Strong organizational, written, and verbal communication skills.
• Analytical and problem‑solving skills and ability to identify technical issues requiring escalation.
• Previous experience managing regulatory system implementations is a plus.

Responsibilities

• With oversight from the Associate Director, Regulatory Systems & Training, and in partnership with QA and IT, support and maintain all operational aspects of Cytokinetics’ regulatory systems.
• Maintain Vault RIM configuration: Lifecycles, workflows, document types/subtypes/classifications, security profiles, and user roles.
• Manage User access requests and training requirements for Regulatory Systems. Provide hands‑on training and end‑user support as needed
• Support the overall end user adoption of new enhancements and processes, leading small to medium initiatives within Regulatory and across other Cytokinetics functions
• Coordinate with Veeva Support and Managed Services for advanced issue resolution, enhancement requests, and best-practice guidance.
• Collaborate with Regulatory Affairs, Regulatory Operations, Quality, and Clinical teams to align RIM capabilities with business needs.
• Support change control processes in partnership with IT/QA for new system releases and enhancements.
• Serve as a key contributor to validation activities for regulatory systems
• Cross‑train with other areas of Regulatory Operations (e.g., Regulatory Project Management, Regulatory Publishing) and provide support, as needed, during periods of peak workload

Skills

Regulatory operations management

Cross-functional collaboration

Analytical problem solving

Strong communication

Training and user support

Education

Bachelor's degree in Life Science, Computer Science, or Business

Tools

Veeva Vault RIM

Job description

Cytokinetics, a cardiovascular biopharmaceutical company, seeks a Sr. Manager Regulatory Operations – Systems to lead regulatory systems management and improvements, focusing on Veeva Vault RIM.

The role partners with QA, IT, and Regulatory teams to maintain configuration, roles, and access while driving adoption of enhancements. You will contribute to the global regulatory submission process, assist with system upgrades, and participate in validation activities, cross-training across Regulatory