Sr Manager/Assoc Director, Regulatory Operations

The role

The Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This person will build and manage the Regulatory Information Management System and lead submission planning and execution.

What you will do

• Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables.
• Track progress, identify risks or dependencies, and drive submission activities to completion.
• Independently lead or coordinate standardized submissions such as DSURs and IBs.
• Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information.
• Support periodic QC reviews of study TMFs and resolve identified documentation gaps.
• Establish and maintain Regulatory document templates, formatting standards, naming conventions, 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.

Required qualifications

• Undergraduate degree
• 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
• Hands-on experience with health authority question and commitment tracking
• Strong project management skills
• 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
• 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

About the company

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. The company's mission is to erase cancer.