Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.
Position Summary:
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.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.
Essential Duties and Responsibilities:
Support Regulatory Affairs submissions including:
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.
Support Regulatory Affairs Department operations, including:
Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including the 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 in accordance with established document management practices
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.
Education and Experience
Undergraduate degree required, advanced degree preferred; RAC certification a plus
6+ years of relevant experience in Regulatory Operations or a closely related field; experience in a small or mid-sized company preferred
Sound knowledge of drug development strategies and regulations
Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role preferred
Hands-on experience with regulatory information management or electronic document management systems and 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, and 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; develops solutions to technical problems and drives change
Able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment
Strong learning orientation, curiosity, and commitment to science and patients
The anticipated salary range for this position is $185,000 to $200,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to…