Associate Director, Regulatory Operations
- Full-time
Overview
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity : The Associate Director, Regulatory Operations will serve as a key publishing lead within the Regulatory Operations function, responsible for managing and executing regulatory submission activities to support the company’s growing pipeline and portfolio. This individual will ensure timely, accurate, and compliant submissions to the FDA and other global Health Authorities while contributing to the effective management of regulatory information, systems, and processes that enable operational efficiency and scalability.
This role is an individual contributor with leadership responsibilities, partnering cross-functionally with clinical, quality, CMC, nonclinical, and regulatory strategy teams to ensure seamless document management, publishing, and submission execution. The Associate Director also plays a key role in maintaining the integrity of regulatory information and ensuring compliance with global health authority requirements in a dynamic, fast-paced environment.
Responsibilities
Regulatory Publishing & Submission Management
- Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.
- Manage submission production and quality control (QC) processes, ensuring compliance with global regulatory requirements and internal standards.
- Provide technical expertise in eCTD publishing tools and platforms (e.g., Veeva Vault RIM) to enable efficient and compliant submission execution.
- Proactively manage publishing timelines from request through archive, anticipating potential issues, escalating risks early, and collaborating with cross-functional teams to adapt plans as needed.
Systems, Tools & Process Optimization
Cross-Functional Leadership & Vendor Oversight
Strategic Contribution & Compliance
Qualifications
Bachelor’s degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.
Preferred Skills
Compensation & Benefits
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
Base Pay Salary Range
$180,000 — $225,000 USD
Additional postings
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