Director, Regulatory Affairs jobs in United States
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Revolution Medicines · 12 hours ago

Director, Regulatory Affairs

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The Director of Regulatory Affairs is responsible for delivering regulatory strategy for oncology programs, mentoring team members, and ensuring alignment across functions to meet program milestones.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs
Motivate, mentor and develop direct reports to ensure development and performance
Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on program milestones
Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success
Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly
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

Qualification

Regulatory strategyOncology drug developmentHealth authority interactionsAlliance managementGlobal regulatory submissionsPlanning skillsLeadershipCommunication skillsOrganizational skills

Required

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
Proven success in developing and delivering global regulatory strategies and submissions
Demonstrated success in leading health authority interactions and negotiations
Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies
Strong track record in alliance management, coordinating with external development or commercialization partners
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

An advanced degree is desirable
Experience with dose optimization in oncology
Prior NDA experience is highly preferred

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase