Senior Manager/Associate Director, Regulatory Operations

Erasca, Inc.

. Lead regulatory operations across the portfolio .

Posted 10/22/2026full-timeSan Diego • California • United StatesSenior💰 $185,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Operations, including submission planning, document management, and regulatory compliance. Proficient in managing regulatory information systems and leading cross-functional teams to ensure timely and high-quality submissions.

Highest-signal resume keywords

Regulatory Operations ManagementSubmission Planning and ExecutionRegulatory Information Management SystemProject Management SkillsRAC Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationDocument ManagementDrug Development RegulationsOperational Dashboard CreationDocument FormattingHealth Authority CorrespondenceSubmission-Ready Document RequirementsQuality Control ReviewsRisk Identification and ManagementRegulatory Record Maintenance

Soft Skills

Strong Learning OrientationCuriosityTeam CollaborationAdaptabilityProblem-Solving

Tools & Technologies

SmartsheetMicrosoft 365Electronic Document Management SystemsRegulatory Information Management Systems

Certifications & Qualifications

Undergraduate DegreeAdvanced Degree PreferredRAC Certification

Industry Keywords

Regulatory AffairsDrug Development StrategiesNDABLAMAASubmission StandardsHealth Authority RegulationsInspection-Ready RepositoriesDocument TemplatesOperational Risks

About the role

Key responsibilities & impact

Lead regulatory operations across the portfolio
Build and manage the Regulatory Information Management System
Lead submission planning and execution
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence
Work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions
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, other regulatory information, and associated trackers
Support periodic QC reviews of study TMFs and resolve 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
Support or lead management of the Regulatory department budget, including forecasts, invoices, and payment approvals
Perform duties in accordance with company values, policies, and applicable regulations

Requirements

What you’ll need

Undergraduate degree required; advanced degree preferred; RAC certification a plus
6+ years of relevant experience in Regulatory Operations or a closely related field
Sound knowledge of drug development strategies and regulations
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
Strong project management skills, including management of strategic deadlines, changing requirements, multiple priorities, and operational risks
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
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

Benefits

Comp & perks

Annual bonus
Equity grant at hire and annually, in the form of an option to purchase stock in the future
Paid Time Off
Holiday and 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
Casual, collaborative, and fun work environment