Revolution Medicines · 3 days ago
Director Regulatory Affairs
Redwood City, California, United States
Full-time
Hybrid
Director/Executive
$211K/yr - $264K/yr
10+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. The Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology and ensure successful regulatory outcomes.
Health CareLife ScienceMedical
Responsibilities
Provide regulatory leadership to clinical development programs in oncology
Independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization
Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs
Translate strategy into specific activities supporting product development and corporate goals
Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence
Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness
Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps
Manage direct report(s) and provide mentorship to junior professionals
Qualification
Required
Degree in biological or life sciences, pharmacy, medicine, or related fields
An advanced degree is desirable
Minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience
Minimum of 6 years in Regulatory Affairs
Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy
Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities
Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management
Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
Preferred
Direct experience with immuno-oncology drug development and checkpoint inhibitors
Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols
Direct experience with FDA expedited programs
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
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 CompanyTotal Funding
$2.25BKey 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
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase