Director, Regulatory Project Management

Cytokinetics is seeking a Director, Regulatory Project Management with a proven track record of partnering with colleagues in Regulatory Affairs and across the broader organization to develop and execute plans for large/complex submissions, operationally manage application lifecycle activities, and support the development and implementation of systems and tools essential to manage regulatory submissions and information.  This role will be accountable for working with strategic Regulatory Affairs functions (including Regulatory Strategy, Regulatory CMC, and Regulatory Labeling) to develop detailed, actionable submission plans, tracking major submission deliverables, and ensuring consistent management submission documents, health authority communications, and all other regulatory information supporting Cytokinetics’s investigational and marketing applications.  In addition, this role will play an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Cytokinetics in the areas of document management, submission content planning, and regulatory information management.

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 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

Qualifications

• 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