Regulatory Systems Lead — Vault RIM & Operations

Cytokinetics; Radnor (Delaware County); Hybrid; USD 177,000 - 207,000; Full time

Benefits offered by this job

Stock options

Health, dental, vision insurance

Life and disability insurance

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics is a specialized cardiovascular biopharmaceutical company focused on muscle biology and a pipeline of medicines for cardiac muscle diseases. The Sr.

Manager Regulatory Operations – Systems will lead operational management of regulatory information management systems, mainly Veeva Vault RIM, and drive continuous improvement across Regulatory Operations. Reporting to the Associate Director, Regulatory Systems & Training, the role requires 5+ years in regulatory systems, strong Veeva

Qualifications

• BS degree in life science, computer science, or business with 5+ years in regulatory systems or publishing.
• Strong knowledge of Veeva Vault RIM, regulatory submissions, and cross-functional collaboration.
• Experience leading regulatory systems implementations and change control processes.

Responsibilities

• Maintain Vault RIM configurations: lifecycles, workflows, document types, security profiles, and user roles.
• Manage user access requests and deliver end-user training for Regulatory Systems.
• Collaborate with Regulatory Affairs, Quality, IT, and Clinical teams to align RIM with business needs.
• Support validation activities and coordinate with QA for system releases and enhancements.
• Coordinate with Veeva Support and Managed Services for issue resolution and improvements.

Skills

Veeva RIM

Regulatory systems management

Regulatory publishing

Training & end-user support

Analytical problem-solving

Education

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

Tools

Veeva Vault RIM

Job description

Cytokinetics is a specialized cardiovascular biopharmaceutical company focused on muscle biology and a pipeline of medicines for cardiac muscle diseases. The Sr.

Manager Regulatory Operations – Systems will lead operational management of regulatory information management systems, mainly Veeva Vault RIM, and drive continuous improvement across Regulatory Operations. Reporting to the Associate Director, Regulatory Systems & Training, the role requires 5+ years in regulatory systems, strong Veeva