Director, Regulatory Affairs (US Filing Lead)

Overview

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The RAS(ON) inhibitors include daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, currently in clinical development. 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

The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation and execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial. The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and strong experience in oncology drug development, US NDA regulations, current Health Authority thinking, and have leadership and problem-solving ability.

Reports into Regulatory Affairs, Global Filing & Registration.

Responsibilities

• Lead cross-functional development and regulatory submission activities for registrational oncology programs in the US.
• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective and consistent regulatory strategies to enable filing and approval of New Drug Applications.
• Develop strategic filing plans under expedited regulatory pathways, programs, and Health Authority initiatives.
• Coordinate NDA filing and sub-team rosters for management endorsement.
• Lead cross-functional NDA kickoff according to global filing plans and framework.
• Maintain and track an integrated filing plan including regulatory timelines, modular NDA deliverables, and critical path activities, in concert with Regulatory Program Management.
• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes; report progress to senior management.
• Drive and/or support modular NDA sub-teams (e.g., across Clinical, Non-Clinical, Product Label) to ensure consistent communication, timely data delivery, and issue resolution.
• Lead relevant Health Authority meetings, interactions and query responses; coordinate cross-functional team preparation and involvement.
• Motivate, mentor and develop direct reports to ensure development and performance.

Qualifications (Required Skills, Experience and Education)

• Degree in life sciences, pharmacy, medicine, or related field with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience, including at least 8 years in Regulatory Affairs with a regulatory strategy role.
• Proven success in executing US NDAs (preparation, submission and approval).
• Experience filing applications under expedited pathways to enable fastest possible regulatory approval.
• Demonstrated ability to lead Health Authority interactions and negotiations.
• In-depth knowledge of CTD structure and dossier components management.
• Direct experience in oncology drug development including oversight of large global Phase 3 registrational studies.
• Flexibility to support business needs of dynamic registrational programs.
• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills

• An advanced degree is desirable.

Compensation and Other Information

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 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.

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Base Pay Salary Range: $211,000 - $264,000 USD.

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