Senior Manager, Regulatory Operations & Systems
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- Previous experience managing regulatory system implementations is a plus.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
