Senior Regulatory Operations Lead (Remote/Hybrid)

OpenKrill; United States; Hybrid; USD 185,000 - 200,000; Full time

Benefits offered by this job

Paid Time Off

Holiday, and Sick Leave

Medical

Dental and Vision Plans

Short- and Long-Term Disability

Life/AD&D Coverage

FSA/HSA and Commute

Critical Illness and Accident Coverage

Pet Insurance

Employee Assistance Program

401(k) Plan with Erasca contribution

Employee Stock Purchase Program

Job summary

Erasca, Inc. is seeking a Sr Manager or Associate Director of Regulatory Operations to lead submissions planning and execution across the portfolio. The role includes building and managing the Regulatory Information Management System and ensuring compliant, timely regulatory submissions.

Remote-friendly across the United States, with hybrid options in San Diego or South San Francisco. The ideal candidate has 6+ years in Regulatory Operations, RAC a plus, and strong PM skills to drive efficiency

Qualifications

• 6+ years of relevant experience in Regulatory Operations or similar field.
• Hands-on experience with regulatory information management and health authority tracking.
• Strong project management skills and ability to manage deadlines and risks.
• Experience creating dashboards or reports with Smartsheet or Microsoft 365.

Responsibilities

• Lead regulatory submissions planning and execution with cross-functional teams.
• Maintain regulatory records, trackers, and archival practices.
• Establish templates and formatting standards for submissions.
• Manage regulatory department budget, invoices and payment approvals.
• Ensure inspection-ready regulatory repositories in compliance with policies.

Skills

Project management

Regulatory knowledge

Cross-functional collaboration

Learning agility

Education

Undergraduate degree

RAC certification

Tools

RIM systems

EDMS

Smartsheet

Microsoft 365

Job description

Erasca, Inc. is seeking a Sr Manager or Associate Director of Regulatory Operations to lead submissions planning and execution across the portfolio. The role includes building and managing the Regulatory Information Management System and ensuring compliant, timely regulatory submissions.

Remote-friendly across the United States, with hybrid options in San Diego or South San Francisco. The ideal candidate has 6+ years in Regulatory Operations, RAC a plus, and strong PM skills to drive efficiency