Manager, Regulatory Affairs jobs in United States
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Revolution Medicines · 1 day ago

Manager, Regulatory Affairs

positionSan Francisco Bay Area
timeFull-time
remoteOnsite
seniorityMid Level
money$143K/yr - $178K/yr
date3+ years exp

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Senior Manager of Regulatory Affairs will provide regulatory advice, manage regulatory activities, and obtain National Health Authority approvals for investigational products.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content
Correspond and collaborate with RevMed colleagues and departments to achieve alignment
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

Regulatory Affairs experienceUS FDA regulationsSuccessful submissionsEU EMA regulationsIND/NDA filingsInterpersonal skillsOrganizational skillsCommunication skillsTeam player

Required

Bachelor's Degree in a relevant field and at least 3 years of direct Regulatory experience
Strong working knowledge of US FDA Pharmaceutical regulations and guidance
Proven track record of successful submissions within a regulatory environment
Exceptionally strong team player with excellent interpersonal and communication skills
Detail-oriented with strong organizational skills and high-quality standards

Preferred

Knowledge of EU EMA Pharmaceutical regulations and guidance preferred
Direct experience with IND/NDA filings

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.
dateFounded in 2015
location
Redwood City, California, USA
people-size501-1000 employees
web-link
https://www.revmed.com

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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Recent News

Benzinga.com
Why Revolution Medicines Shares Are Sliding After Hours On Wednesday
2026-01-09
GlobeNewswire
Revolution Medicines Announces FDA Breakthrough Therapy Designation for Zoldonrasib
2026-01-09
Benzinga.com
Immuneering, Phathom Pharmaceuticals, Canadian Solar And Other Big Stocks Moving Lower In Thursday's Pre-Market Session
2026-01-09
Company data provided by crunchbase