Director, Regulatory Affairs
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 company’s RAS(ON) inhibitors 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, are 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:
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Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
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Anticipate regulatory needs to deliver on program milestones.
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Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success.
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Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
Required Skills, Experience and Education:
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Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
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Proven success in developing and delivering global regulatory strategies and submissions, working independently.
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Previous experience with NDA and/or global marketing application filings.
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Previous experience with global ODD annual reports.
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Demonstrated success in leading health authority interactions and negotiations.
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Direct experience in oncology drug development including oversight of large, global Phase 3 studies.
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Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
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Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills:
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An advanced degree is desirable.
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Experience with dose optimization in oncology.
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Prior NDA experience.
#LI-Hybrid #LI-SH1
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.
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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
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