Regulatory Operations Lead — Sr Manager/AD (Remote)

Erasca, Inc.; San Diego, South San Francisco (CA, CA); Hybrid; USD 185,000 - 200,000; Full time

Benefits offered by this job

Annual bonus

Equity grant

401(k) Plan with Erasca contribution

Job summary

Erasca, Inc. is seeking a Sr Manager/Assoc Director, Regulatory Operations in a role that can be based in San Diego, South San Francisco, or remotely across the United States.

The position leads regulatory operations, builds and manages the Regulatory Information Management System, and drives submission planning with cross-functional teams to ensure timely, high-quality regulatory filings.

Qualifications

• 6+ years of regulatory operations experience in a pharma/biotech setting.
• Experience supporting NDA/BLA/MAA submissions or major amendments preferred.
• Hands-on with regulatory information management systems and document management practices.
• Strong ability to manage deadlines, scope, and risks in a fast-paced environment.
• Experience creating portfolio dashboards or reports.

Responsibilities

• Lead regulatory operations across the portfolio and manage the Regulatory Information Management System.
• Oversee submission planning, execution, and health authority correspondence.
• Maintain submission records, templates, and archival practices.
• Support or lead budget management, forecasts, invoices, and approvals.
• Ensure inspection-ready regulatory repositories and compliant document management.

Skills

Regulatory submissions

Regulatory information management

Health authority correspondence

Project management

Document management systems

Templates and standards

Cross-functional collaboration

Tools

Smartsheet

Microsoft 365

Job description

Erasca, Inc. is seeking a Sr Manager/Assoc Director, Regulatory Operations in a role that can be based in San Diego, South San Francisco, or remotely across the United States.

The position leads regulatory operations, builds and manages the Regulatory Information Management System, and drives submission planning with cross-functional teams to ensure timely, high-quality regulatory filings.