Director, Regulatory Affairs (Global Filing Lead)

Revolution Medicines; San Francisco (CA); On-site; USD 211,000 - 264,000; Full time

Benefits offered by this job

Competitive cash compensation

Robust equity awards

Strong benefits

Significant learning opportunities

Job summary

A biopharmaceutical company is seeking a Director of Regulatory Affairs to oversee global regulatory submissions for oncology programs. The role involves leading cross-functional team efforts, ensuring compliance, and providing strategic regulatory advice. Candidates should have at least 12 years of experience in the pharmaceutical sector with strong knowledge of regulatory processes, specifically for NDA/MAAs. The position offers a competitive salary range of $211,000 - $264,000, reflective of market conditions and candidate qualifications.

Qualifications

• Minimum of 12 years in the pharmaceutical/biotech industry.
• 8+ years of experience in Regulatory Affairs.
• Proven success in executing global NDA/MAA submissions.

Responsibilities

• Drive preparation and execution of global NDA/MAA filings.
• Manage cross-functional coordination for submissions.
• Support drug development teams with regulatory advice.

Skills

Oncology drug development

Regulatory strategy execution

Global NDA/MAA submissions

Health Authority interactions

Excellent communication skills

Education

Degree in life sciences, pharmacy, or medicine

Job description

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 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 (Global Filing Lead) is accountable for driving preparation & execution of global 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 & global filing 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 EU, UK, Japan and internationally.
• 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 dossier filing and sub-team rosters for management endorsement.
• Lead cross-functional MAA kickoff according to global filing plans and framework.
• Maintain & track an integrated filing plan including regulatory timelines, modular MAA deliverables, critical path activities, in concert with Regulatory Program Management.
• Identify, respond to, and proactively mitigate risks to filing 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.

Required Skills, Experience and Education

• 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 global NDA/MAAs (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.

Preferred Skills

• Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.
• 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.

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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