Director, Regulatory Affairs - US Filing Lead at Revolution Medicines

You're a seasoned regulatory affairs professional with at least 12 years in pharma/biotech, including 8 in regulatory affairs with a strategy focus, ready to le

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

You're a seasoned regulatory affairs professional with at least 12 years in pharma/biotech, including 8 in regulatory affairs with a strategy focus, ready to lead US NDA filings for late-stage oncology drugs. **What makes it worth a look...** This is a full-time, hybrid Director, Regulatory Affairs position at Revolution Medicines, a company focused on novel targeted therapies, with a base salary range of $211,000 - $264,000 per year in Redwood City, California. **You might be a good fit if you...** * Have a proven track record of successfully executing US NDAs, including preparation, submission, and approval. * Possess in-depth knowledge of CTD structure and experience managing dossier components. * Have direct experience in oncology drug development, including oversight of large Phase 3 registrational studies. * Are skilled at leading Health Authority interactions and negotiations.

Job Description

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:

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

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.

• 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.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing 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 & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.

• 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.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

• 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.

• Proven success in executing US NDAs (preparation, submission & approval)

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• 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.

• An advanced degree is desirable.

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.

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