Revolution Medicines · 5 months ago
Associate Director, Regulatory Affairs
Redwood City, California, United States
Full-time
Onsite
Senior Level
$180K/yr - $225K/yr
7+ 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 Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams, provide actionable advice, and ensure successful regulatory outcomes.
Health CareLife ScienceMedical
Responsibilities
Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks
Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence
Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction
Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives
Able to proactively identify risks and devise mitigation strategies
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams
Perform regulatory research to inform business strategy. Assess and communicate risks
Assure that there are no significant interruptions to the business due to regulatory compliance issues
Collaborates across the organization at all levels, across functional groups, and with executive management
Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations
Qualification
Required
Bachelor's Degree in a relevant field, an advanced degree is desirable
Minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience
Minimum of 5 years in Regulatory Affairs
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 communicator
Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance
Preferred
Direct experience with oncology drug development highly preferred
Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred
Direct experience with FDA expedited programs 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
2026-01-09
2026-01-09
Company data provided by crunchbase