Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Reporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. The role will work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.
Responsibilities
Lead regulatory operations across the portfolio; build and manage the Regulatory Information Management System; lead submission planning and execution; establish efficient processes for regulatory records, document management, publishing, and health authority correspondence; partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables; proactively track progress, identify risks or dependencies, and drive submission activities to completion; may independently lead/coordinate standardized submissions, such as DSURs, IBs, etc.; maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including timely update of associated trackers; support periodic QC reviews of study TMFs and resolve identified documentation gaps; establish and maintain regulatory document templates, formatting standards, naming conventions, submission-ready document requirements, and archival practices; maintain organized and inspection-ready regulatory repositories and archives; support or lead management of the Regulatory department budget, including forecasts, invoices, and payment approvals; perform all duties in keeping with the Company's core values, policies, and all applicable regulations
Requirements
Undergraduate degree required; 6+ years of relevant experience in Regulatory Operations or a closely related field; sound knowledge of drug development strategies and regulations; hands-on experience with regulatory information management or electronic document management systems; experience with health authority question and commitment tracking; strong project management skills, with the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks; experience with document formatting and authoring templates; experience training colleagues on business processes, RIM or EDMS practices, and submission standards; experience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools; demonstrated interest and ability to learn new things; able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment; strong learning orientation, curiosity, and commitment to science and patients
Nice to have
Advanced degree; RAC certification; experience in a small or mid-sized company; experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role
Benefits
Paid Time Off, Holiday, and Sick Leave; Medical, Dental and Vision Plans; Short- and Long-Term Disability; Basic and Voluntary Life/AD&D Coverage; Flexible Spending Accounts (FSA, HSA, and Commute); Critical Illness and Accident Coverage; Pet Insurance; Employee Assistance Program; 401(k) Plan with Erasca contribution; Employee Stock Purchase Program; annual bonus eligibility; equity grant at hire and annually
Stany Zjednoczone · South San Francisco
