Senior Manager, Regulatory Operations - Systems

Cytokinetics; Radnor (Delaware County); Hybrid; USD 177,000 - 207,000; Full time

Benefits offered by this job

Stock options

Health, dental, vision insurance

Life and disability insurance

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics is a specialized cardiovascular biopharmaceutical company focused on muscle biology and a pipeline of medicines for cardiac muscle diseases. The Sr.

Manager Regulatory Operations – Systems will lead operational management of regulatory information management systems, mainly Veeva Vault RIM, and drive continuous improvement across Regulatory Operations. Reporting to the Associate Director, Regulatory Systems & Training, the role requires 5+ years in regulatory systems, strong Veeva

Qualifications

• BS degree in life science, computer science, or business with 5+ years in regulatory systems or publishing.
• Strong knowledge of Veeva Vault RIM, regulatory submissions, and cross-functional collaboration.
• Experience leading regulatory systems implementations and change control processes.

Responsibilities

• Maintain Vault RIM configurations: lifecycles, workflows, document types, security profiles, and user roles.
• Manage user access requests and deliver end-user training for Regulatory Systems.
• Collaborate with Regulatory Affairs, Quality, IT, and Clinical teams to align RIM with business needs.
• Support validation activities and coordinate with QA for system releases and enhancements.
• Coordinate with Veeva Support and Managed Services for issue resolution and improvements.

Skills

Veeva RIM

Regulatory systems management

Regulatory publishing

Training & end-user support

Analytical problem-solving

Education

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

Tools

Veeva Vault 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.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.ResponsibilitiesWith 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 neededSupport the overall end user adoption of new enhancements and processes, leading small to medium initiatives within Regulatory and across other Cytokinetics functionsCoordinate 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 systemsCross-train with other areas of Regulatory Operations (e.g., Regulatory Project Management, Regulatory Publishing) and provide support, as needed, during periods of peak workloadQualificationsBachelor’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.#LI-HYBRIDPay Range:The expected salary range for this position based on the primary location of Radnor, PA is $177,300-$206,850. 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.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.Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and OffersRecently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:We do not conduct job interviews through non-standard text messaging applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail] visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer