Regulatory Systems Lead, Vault RIM & Operations

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

Benefits offered by this job

Stock options/RSUs

Comprehensive health/dental/vision

401k with employer match

Paid time off

Job summary

Cytokinetics in South San Francisco, CA is seeking a Sr. Manager Regulatory Operations - Systems to lead and optimize regulatory information management systems, with a primary focus on Veeva Vault RIM.

You will manage system configurations, oversee user access and training, and collaborate with Regulatory Affairs, QA, IT, and Clinical teams to align RIM capabilities with business needs. The role includes supporting upgrades, validation activities, and cross-training within Regulatory Operations.

Qualifications

• Bachelor's degree in Life Science, Computer Science, or Business with 5+ years' experience in regulatory operations systems.
• Strong understanding of Veeva RIM and global regulatory submission requirements.
• Excellent organizational, written and verbal communication skills.

Responsibilities

• 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 and training requirements; provide hands-on training and end-user support.
• Coordinate with Veeva Support and Managed Services for issue resolution and enhancements.
• Collaborate with Regulatory Affairs, Regulatory Operations, QA, and Clinical teams to align RIM with business needs.
• Assist with 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 and provide support during peak workload.

Skills

Veeva Vault RIM

Regulatory systems management

Training & support

Stakeholder collaboration

Analytical problem-solving

Education

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

Tools

Veeva Vault RIM

Job description

Cytokinetics in South San Francisco, CA is seeking a Sr. Manager Regulatory Operations - Systems to lead and optimize regulatory information management systems, with a primary focus on Veeva Vault RIM.

You will manage system configurations, oversee user access and training, and collaborate with Regulatory Affairs, QA, IT, and Clinical teams to align RIM capabilities with business needs. The role includes supporting upgrades, validation activities, and cross-training within Regulatory Operations.