Senior Manager, Regulatory Operations - Systems

Cytokinetics seeks a Senior Manager for Regulatory Operations to oversee and enhance the company's regulatory information management systems, primarily Veeva Vault RIM. The role involves maintaining system configurations, managing user access, supporting process improvements, and collaborating across regulatory and clinical teams.

Responsibilities

• Maintain Veeva Vault RIM configurations including lifecycles, workflows, document types, and security profiles
• Manage user access requests, training requirements, and provide hands-on end-user support
• Lead small to medium regulatory system initiatives and support adoption of enhancements
• Coordinate with Veeva Support and managed services for issue resolution and best-practice guidance
• Collaborate with Regulatory Affairs, Operations, Quality, and Clinical teams on system alignment

Requirements

• Bachelor's degree in Life Science, Computer Science, or Business
• 5+ years managing regulatory operations systems or regulatory publishing
• Strong expertise with Veeva RIM and global regulatory submission requirements
• Excellent organizational, written, and verbal communication skills
• Analytical and problem-solving abilities with technical escalation judgment
• Previous regulatory system implementation experience preferred

Compensation: $177,300-$206,850 base