Senior Manager, Regulatory Operations & Systems

Cytokinetics (Ireland) Limited; South San Francisco (CA); Hybrid; USD 181,000 - 211,000; Full time

Benefits offered by this job

Stock options

Restricted stock units

Health insurance

401k with employer match

Wellness stipends

Paid time off

Job summary

Cytokinetics is seeking a Sr. Manager Regulatory Operations – Systems to support operational management and continuous improvement of Regulatory Information Management systems, with a focus on Veeva Vault RIM, based in South San Francisco, CA.

The role involves supporting system upgrades, day-to-day operations, and contributing to the regulatory systems roadmap, with hybrid work arrangements and a comprehensive compensation package.

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, 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.

Responsibilities

• Support and maintain all operational aspects of Cytokinetics’ regulatory systems under supervision.
• 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 with hands-on support.
• Lead small to medium initiatives within Regulatory and across Cytokinetics functions.
• Coordinate with Veeva Support and Managed Services for issue resolution and enhancement requests.
• Collaborate with Regulatory Affairs, Regulatory Operations, Quality, and Clinical teams to align RIM capabilities with business needs.
• Support change control processes for new releases and enhancements.
• Contribute to validation activities for regulatory systems.
• Cross-train with other areas and provide support during peak workload.

Skills

Veeva Vault RIM

Regulatory systems management

Regulatory publishing

Project coordination

Analytical problem-solving

Cross-functional collaboration

Education

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

Tools

Veeva Vault

Job description

Cytokineticsis 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.

Cytokinetics is seeking a Sr. Manager Regulatory Operations – Systems to support operational management and continuous improvement of Cytokinetics’s Regulatory Information Management systems and processes, with a primary focus on Veeva Vault RIM. This role will be responsible for assisting with regulatory systems projects/upgrades, supporting day-to-day operational use of the systems, and will be a major contributor in the overall vision of the regulatory systems roadmap.

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.

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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.

• 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

Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer