Revolution Medicines · 8 hours ago
Therapeutic Area Head of Regulatory Affairs
Redwood City, California, United States
Full-time
Hybrid
Director/Executive
$244K/yr - $305K/yr
12+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The role involves providing management and leadership for late-stage oncology programs, overseeing global regulatory strategies, and fostering staff development within the therapeutic area.
Health CareLife ScienceMedical
Responsibilities
Provide management and leadership of one or more therapeutic areas for late-stage oncology programs
Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions
Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies
Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities
Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape
Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas
Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning
Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies
Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management
Conduct management review and approval of key documents for regulatory submissions and governance communications
Contribute to the target product profile and evaluation of probability of regulatory success
Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment
Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions
Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals
Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures
Qualification
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
Prior marketing application filing experience. Demonstrated success in obtaining health authority approvals
Demonstrated ability in leading teams, establishing organizational direction, and championing continuous improvements
Direct experience with global oncology drug development
Experienced in representing Regulatory on cross functional teams and presenting to senior management. Proven ability to anticipate challenges and future risks and mitigate against potential strategic issues
Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
Preferred
An advanced degree is desirable
Experience with combination studies, multiple expansion cohort, global registrational studies, basket or umbrella and master protocols highly preferred
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