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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Revolution Medicines is seeking a Senior Manager, Regulatory Planning, who will be responsible for continuing to build and executing the Regulatory Planning function. Regulatory Planning is responsible for collection of timing of regulatory submissions and activities globally and across programs and aggregating and reporting this information in efficient and useful ways. This role is an individual contributor with team leadership responsibilities, reporting into the head and Sr. Director, Regulatory Operations & Planning.

• Understand regulatory submissions and activities.

• Ensure effective communication of regulatory submissions and activities globally, to help ensure timely and accurate dissemination of regulatory workstreams.

• Identify, establish, and manage databases/information sources to track key deliverables and information.

• Provide scenario and visualization support to drive proactive planning and rapid and informed decision making.

• Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates.

• Identify regulatory bottlenecks or resource constraints based on Planning outputs.

• Demonstrate strategic mindset to support comprehensive strategies that align with organizational goals and regulatory requirements for efficient execution.

• Identifies opportunities for process improvements and create best practices.

• Manages the input, upkeep, and revisions of project plans for assigned projects, highlighting any unforeseen changes in resource requirements.

Required Skills, Experience and Education:

• 5+ years of Regulatory Planning or equivalent experience.

• Proficient in Smartsheet and OnePager.

• Understanding of eCTD and relevant submission formatting, transmittal and archiving regulations and guidelines.

• Knowledge of ex-US eCTD submissions and submissions processes.

• Foster strong collaborative relationships with external partners and vendors to ensure both high quality of submissions and compliance with regulatory processes and standards.

• Outstanding interpersonal and communication (written and verbal) skills: able to work with multiple groups of people at one time, remaining calm, professional, diplomatic and positive.

Preferred Skills:

• Proficient in MS Project and TimelinePro.

• Submissions to multiple FDA divisions, especially oncology, experience a plus.

The base salary range for this full-time position is $135,000 to $175,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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 [email protected].

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