Senior Manager, Regulatory Operations & Systems

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 181,000 - 211,000; Full time

Benefits offered by this job

Equity in stock options and RSUs

Comprehensive health

Dental

Vision

Life and disability insurance

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. in South San Francisco is seeking a Sr. Manager Regulatory Operations – Systems to oversee regulatory systems, including Vault RIM configuration, access control, and user training.

You will lead validation efforts and coordinate with QA, IT, and cross‑functional teams to drive system improvements. The ideal candidate has a life sciences or technical background with 5+ years managing regulatory systems or publishing, strong communication skills, and experience with global

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, 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 requests and training requirements for Regulatory Systems.
• Provide hands‑on training and end‑user support as needed.
• Support end user adoption of enhancements and processes, leading small to medium initiatives.
• 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.
• Support change control processes for new system releases and enhancements.
• Contribute to validation activities for regulatory systems.
• Cross-train with other Regulatory Operations areas and provide support during peak workloads.

Skills

Organizational skills

Written communication

Verbal communication

Analytical problem-solving

Education

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

Tools

Veeva RIM

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Sr. Manager Regulatory Operations – Systems

Responsibilities

• With oversight from the Associate Director, Regulatory Systems & Training, and in partnership with QA and IT, 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 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.

Qualifications

• Bachelor’s degree in Life Science, Computer Science, or Business, with 5+ years of managing regulatory operations systems or regulatory publishing.
• Strong understanding of Veeva RIM, supporting/maintaining regulatory operations systems, and global regulatory submission requirements.
• Strong organizational, written, and verbal communication skills.
• Analytical and problem‑solving skills and ability to identify technical issues requiring escalation.
• Previous experience managing regulatory system implementations is a plus.

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $181,260-$211,470. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Benefits

• equity in the form of stock options and/or restricted stock units
• comprehensive health
• dental
• vision
• life and disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off

Our employees come from different backgrounds, and we celebrate those differences.

Cytokinetics is an Equal Opportunity Employer

Fraud Warning

How to Identify Impersonated Cytokinetics Job Postings and Offers

• We do not conduct job interviews through non‑standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
• We will never request that you purchase equipment or other items when interviewing or hiring
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail]

Please visit our website at: www.cytokinetics.com