Cytokinetics is hiring a
Director Regulatory Project Management, Remote - United States

Summary

Cytokinetics is seeking a Director, Regulatory Project Management with 12+ years of experience in various Regulatory Operations disciplines. The role includes partnering with colleagues to develop submission plans, tracking major deliverables for regulatory submissions, and overseeing the build and maintenance of submission assemblies within Cytokinetics EDMS.

Requirements

• Broad range of experience across various Regulatory Operations disciplines including regulatory submission management, regulatory publishing, and regulatory systems (12+ years)
• Proven track record of supporting Regulatory Affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to interpret technical regulatory submission guidelines, translating them to specific submission requirements
• Strong project management and critical thinking skills
• Strong written and verbal communication skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Previous experience supporting regulatory systems implementations (e.g., EDMS, RIM)
• Working understanding of CSV principles desired
• Bachelor’s degree required

Responsibilities

• Partners with Regulatory Affairs strategic functions – including Regulatory Strategy, Regulatory CMC, and Labeling – to develop and execute detailed submission plans and support submission compilation within they Cytokinetics EDMS
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Serves as a key subject matter expert in the development, implementation, maintenance, and training for EDMS, RIM, and other systems as needed
• Works closely with colleagues in IT and QA to ensure the business provides adequate support for validation activities for EDMS, RIM, and other systems owned by Regulatory Affairs
• Develops and maintains submission plan templates to ensure Cytokinetics regulatory submissions are consistently planned and executed across programs
• Oversees the build and maintenance of submission assemblies within the Cytokinetics EDMS
• In partnership with colleagues in Regulatory Operations and Regulatory Affairs, provides guidance to submissions teams relative to technical requirements for regulatory submissions (e.g., eCTD guidances, study data standards)
• As needed, develops/supports development of new and updated processes related to submission production and use of Regulatory Affairs systems
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed