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Senior Manager, Regulatory Operations & Systems

$181.26k - $211.47k

Cytokinetics

Cytokinetics seeks a Senior Manager for Regulatory Operations & Systems to oversee maintenance and optimization of regulatory information management systems, particularly Veeva Vault RIM. The role involves system configuration, user support, and process improvements across regulatory and related functions.

Responsibilities

  • Maintain Vault RIM configuration including lifecycles, workflows, document types, security, and user roles
  • Manage user access requests, training requirements, and provide hands-on end-user support
  • Lead small to medium regulatory system enhancements and adoption initiatives
  • Coordinate with Veeva Support and internal teams for issue resolution and best-practice alignment
  • Support validation activities and change control processes for system releases and enhancements

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 and communication skills, written and verbal
  • Analytical and problem-solving abilities with technical issue escalation judgment
  • Experience with regulatory system implementations preferred

Compensation: $181,260-$211,470 base

Vacancy posted 21 days ago
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