Sobre esta vaga de Director, Regulatory Affairs (US Filing Lead) na Revolution Medicines
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
The Opportunity:
The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & 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 be highly experienced in oncology drug development, US NDA regulations, current Health Authority thinking, and have strong leadership & problem-solving ability.
Reports into Regulatory Affairs, Global Filing & Registration
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High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.
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Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.
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Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.
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Coordinate NDA Filing and Sub-team rosters for management endorsement.
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Lead cross-functional NDA kickoff according to global filing plans and framework.
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Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.
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Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.
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Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.
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Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.
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Motivate, mentor and develop direct reports to ensure development and performance.
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 a regulatory strategy role.
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Proven success in executing US NDAs (preparation, submission & approval).
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Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.
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Demonstrated ability to lead Health Authority interactions and negotiations.
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In-depth knowledge of CTD structure and management of dossier components.
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Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.
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Flexibility to support business needs of dynamic registrational programs.
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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.
#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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We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
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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