Remote opportunity at
Erasca, Inc.Sr Manager/Assoc Director, Regulatory Operations
Erasca, Inc. seeks a Sr Manager/Assoc Director, Regulatory Operations to direct regulatory operations across the corporate portfolio. Operating under the Chief Regulatory Affairs Officer, this individual…
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About This Role
Erasca, Inc. seeks a Sr Manager/Assoc Director, Regulatory Operations to direct regulatory operations across the corporate portfolio. Operating under the Chief Regulatory Affairs Officer, this individual will establish and manage the Regulatory Information Management System, direct submission planning and execution, and maintain efficient processes for regulatory records, publishing, document management, and health authority correspondence. The position requires close collaboration with Regulatory Affairs and cross-functional partners to facilitate prompt, high-quality submissions.…
Job Description
Erasca, Inc. seeks a Sr Manager/Assoc Director, Regulatory Operations to direct regulatory operations across the corporate portfolio. Operating under the Chief Regulatory Affairs Officer, this individual will establish and manage the Regulatory Information Management System, direct submission planning and execution, and maintain efficient processes for regulatory records, publishing, document management, and health authority correspondence. The position requires close collaboration with Regulatory Affairs and cross-functional partners to facilitate prompt, high-quality submissions.
This role suits professionals with extensive background in regulatory operations who excel in dynamic, fast-paced settings. Erasca is a clinical-stage precision oncology enterprise dedicated to discovering, developing, and commercializing cancer therapeutics by targeting the RAS/MAPK signaling pathway. Candidates have the flexibility to work fully remote anywhere across the United States or on a hybrid schedule out of the San Diego or South San Francisco offices.
Responsibilities
- Collaborate with Regulatory Leads and cross-functional teams to define submission contents, responsibilities, deliverables, and timelines while tracking progress and managing risks
- Independently coordinate and lead standardized submissions such as Investigators Brochures and Development Safety Update Reports
- Maintain accurate records of regulatory submissions, commitments, correspondence, and trackers
- Perform periodic quality control reviews of trial master files and address documentation gaps
- Create and maintain regulatory document templates, naming conventions, formatting standards, and archival practices
- Keep regulatory repositories organized and inspection-ready
- Support or oversee the regulatory department budget including forecasts, invoices, and payment approvals
Requirements
- Undergraduate degree
- Minimum of six years of relevant experience within regulatory operations or a closely related field
- Demonstrated hands-on experience utilizing electronic document management systems or regulatory information management systems
- Experience tracking health authority commitments and questions
- Project management skills involving strategic deadlines, changing needs, and operational risk management
- Familiarity with authoring templates, document formatting, and training colleagues on business processes or submission standards
- Experience building operational dashboards or portfolio reporting utilizing Microsoft 365, Smartsheet, or comparable tools
Qualifications
- Advanced degree
- Regulatory Affairs Certification
- Experience working in a small or mid-sized company
- Understanding of drug development regulations and strategies
- Operational leadership experience supporting or preparing marketing applications like an NDA, BLA, or MAA, or a major amendment
Core Skills
Benefits
- Annual bonus eligibility
- Initial and annual equity grants in the form of stock options
- Paid time off, holidays, and sick leave
- Medical, dental, and vision insurance plans
- Short- and long-term disability coverage
- Basic and voluntary life and AD&D coverage
- Flexible spending accounts for FSA, HSA, and commuter expenses
- Critical illness and accident coverage
- Pet insurance
- Employee assistance program
- 401(k) plan with company contribution
- Employee stock purchase program
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Where is this position located?
The role can be performed fully remote from anywhere in the United States or on a hybrid schedule in the San Diego or South San Francisco offices.
What is the expected salary range for this job?
The anticipated base salary ranges from $185,000 to $200,000, with the final offer depending on factors such as industry and job-specific experience and education.
What experience level is required?
Candidates must have an undergraduate degree alongside six or more years of relevant experience in regulatory operations or a closely related field.
What additional compensation is offered beyond base salary?
Hired applicants are eligible for an annual bonus, stock option equity grants upon hire and annually, a 401(k) plan with company contributions, and an employee stock purchase program.
Sample Interview Questions
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