Sr Manager/Assoc Director, Regulatory Operations

Erasca•San Diego, CA

1d•Remote

About The Position

The Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across Erasca’s portfolio. Reporting to the Chief Regulatory Affairs Officer, this person 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 in Erasca’s San Diego or South San Francisco locations, or fully remote anywhere in the United States. The successful candidate will support regulatory submissions and department operations, maintain accurate and inspection-ready regulatory information and repositories, and may support or lead management of the Regulatory department budget.

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.
Hands-on experience with regulatory information management or electronic document management systems, and with health authority question and commitment tracking.
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 with 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.

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.
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 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 duties in keeping with the Company’s core values, policies, and applicable regulations.

Benefits

Annual bonus and equity grant at hire and annually, in the form of an option to purchase stock in the future at a specified price.
Paid time off, holiday, and sick leave.
Medical, dental, and vision plans.
Short- and long-term disability coverage.
Basic and voluntary life and 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.
Casual, collaborative, and fun work environment.