Associate Director, Regulatory Operations

Associate Director, Regulatory Operations

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.

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

Required Skills, Experience and Education :

Preferred Skills :