Sr Manager/Assoc Director, Regulatory Operations

OpenKrill; United States; Hybrid; USD 185.000 - 200.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Project management

Regulatory knowledge

Cross-functional collaboration

Learning agility

Ausbildung

Undergraduate degree

RAC certification

Tools

RIM systems

EDMS

Smartsheet

Microsoft 365

Jobbeschreibung

Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary:

Reporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual 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 will work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.

Essential Duties and Responsibilities:

• Support Regulatory Affairs submissions including:
• Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables; proactively track progress, identify risks or dependencies, and drive submission activities to completion
• May independently lead/coordinate standardized submissions, such as DSURs, IBs, etc.
• Support Regulatory Affairs Department operations, including:
• Maintain accurate regulatory submission records, correspondence, commitments, and other regulatory information, including the timely update of associated trackers
• Support periodic QC 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 all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Education and Experience

• Undergraduate degree required, advanced degree preferred; RAC certification a plus
• 6+ years of relevant experience in Regulatory Operations or a closely related field; experience in a small or mid-sized company preferred
• 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 with health authority question and commitment tracking
• Strong project management skills, with 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; develops solutions to technical problems and drives change
• Able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment
• Strong learning orientation, curiosity, and commitment to science and patients

The anticipated salary range for this position is $185,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes:

• 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
• the opportunity to participate in an Employee Stock Purchase Program.

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race , religion, national origin , ancestry , physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.