Sr Manager/Assoc Director, Regulatory Operations

Erasca • San Diego, CA

1d • $185,000 - $200,000 • Remote

About The Position

Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. Its programs target the RAS/MAPK pathway. The Sr Manager or Associate Director, Regulatory Operations reports to the Chief Regulatory Affairs Officer and leads 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 works closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.

The position may be hybrid at Erasca’s San Diego or South San Francisco locations, or fully remote anywhere in the United States. The anticipated salary range is $185,000 to $200,000. The final salary depends on factors including relevant experience and education. In addition to base salary, the successful candidate is eligible for an annual bonus and an equity grant at hire and annually, in the form of an option to purchase stock at a specified price.

Erasca describes its work environment as casual, collaborative, and fun and offers a comprehensive benefits package. The company is an Equal Opportunity Employer and states that it maintains a diverse and inclusive environment.

Requirements

• Undergraduate degree required.
• At least 6 years of relevant experience in Regulatory Operations or a closely related field.
• Sound knowledge of drug development strategies and regulations.
• Strong project management skills, including 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 using Smartsheet, Microsoft 365, or comparable tools.
• Demonstrated interest and ability to learn new things, develop solutions to technical problems, and drive change.
• Ability to work in an entrepreneurial, fast-paced, dynamic, team-oriented environment.
• Strong learning orientation, curiosity, and commitment to science and patients.

Nice To Haves

• Advanced degree preferred; RAC certification is a plus.
• Experience in a small or mid-sized company preferred.
• 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 health authority question and commitment tracking.

Responsibilities

• 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, as needed.
• Support Regulatory Affairs submissions and department operations.
• Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including timely updates to associated trackers.
• Support periodic quality-control 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, 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 duties in accordance with the Company’s core values, policies, and applicable regulations.

Benefits

• Paid time off, holiday, and sick leave
• Medical, dental, and vision plans
• Short- and long-term disability coverage
• 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
• Opportunity to participate in an Employee Stock Purchase Program
• Annual bonus
• Equity grant at hire and annually in the form of an option to purchase stock at a specified price

What This Job Offers

• Job Type: Full-time
• Career Level: Senior