Senior Manager, Regulatory Operations & Systems

Scorpion Therapeutics; California (MO); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Stock options

Benefits package

Job summary

Cytokinetics is seeking a Senior Manager of Regulatory Operations Systems to lead and optimize regulatory information management systems, primarily Veeva Vault RIM. This role ensures accurate configurations, user access, and adoption of new features across Regulatory Affairs, QA, IT, and Clinical teams to meet global submission needs.

The position emphasizes system validation, change control, and strong collaboration with cross-functional partners to align systems with business objectives.

Qualifications

• Bachelor's degree in Life Science, Computer Science, or Business.
• 5+ years managing regulatory systems or publishing.
• Strong knowledge of Veeva RIM and global regulatory requirements.

Responsibilities

• Maintain system configurations for Regulatory Operations systems.
• Manage user access and provide end-user training.
• Facilitate adoption of new features and changes.
• Coordinate with IT, QA, Regulatory Affairs, and Clinical teams.
• Support validation and change control processes.

Skills

Veeva Vault RIM

Regulatory systems

Access management

Training & adoption

Cross-functional collaboration

Education

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

Tools

Veeva Vault

Job description

Role: Senior Manager of Regulatory Operations Systems at Cytokinetics, focusing on supporting and enhancing regulatory information management systems, primarily Veeva Vault RIM. Responsibilities include maintaining system configurations, managing user access and training, facilitating end-user adoption of new features, coordinating with support services, and supporting validation and change control processes. Collaboration spans Regulatory Affairs, QA, IT, and Clinical teams to align systems with business needs.

Requirements

Bachelor's in Life Science, Computer Science, or Business; 5+ years managing regulatory systems or publishing, with strong knowledge of Veeva RIM and global regulatory requirements; excellent communication, organizational, and problem-solving skills.

Preferred

Experience managing regulatory system implementations.

HighValue

focus on regulatory systems in biopharma, supporting global submissions, validation activities, and cross-functional collaboration.

WorkSetup

Based in South San Francisco, CA, with a compensation package including salary, stock options, and benefits.