Regulatory Systems Lead — Vault RIM & Training (Hybrid)

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

Benefits offered by this job

Stock options and RSUs

Health, dental, vision, life insurance

401k with match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics seeks a Manager Regulatory Operations – Systems to oversee and improve the Regulatory Information Management systems, with a primary focus on Vault RIM. You will collaborate across Regulatory Affairs, QA and IT to ensure systems meet global submission needs and drive adoption of new enhancements.

The role requires 5+ years in regulatory operations systems, strong Veeva experience, and excellent communication and organizational skills.

Qualifications

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

Responsibilities

• With oversight from the Associate Director, Regulatory Systems & Training, support and maintain all operational aspects of Cytokinetics’s 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

Organizational skills

Written communication

Verbal communication

Analytical thinking

Education

Bachelor's degree in Life Science/CS/Business

Tools

Veeva Vault RIM

Job description

Cytokinetics seeks a Manager Regulatory Operations – Systems to oversee and improve the Regulatory Information Management systems, with a primary focus on Vault RIM. You will collaborate across Regulatory Affairs, QA and IT to ensure systems meet global submission needs and drive adoption of new enhancements.

The role requires 5+ years in regulatory operations systems, strong Veeva experience, and excellent communication and organizational skills.