Revolution Medicines · 1 day ago
Vice President, Global CMC Regulatory
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
$294K/yr - $367K/yr
18+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. They are seeking a Vice President, Global CMC Regulatory to lead the global chemistry, manufacturing, and controls regulatory strategy and execution across all development programs and commercial assets.
Health CareLife ScienceMedical
Responsibilities
Develop and execute global CMC regulatory strategies in alignment with product development plans for clinical and commercial programs / marketed products
Provide strategic CMC regulatory leadership to support global filings, approvals, and post-approval lifecycle management
Proactively identify and manage CMC regulatory risks, anticipate challenges and develop mitigation strategies to support business objectives and ensure global alignment and compliance
Serve as the primary CMC regulatory interface with global health authorities, including FDA, EMA, EU National Competent Authorities, and PMDA
Lead and support CMC-related regulatory meetings, scientific advice, and responses to health authority questions
Oversee the preparation, review, and submission of high-quality CMC sections for NDAs, MAAs, J-NDAs, and global post-approval variations
Ensure consistency, compliance, and scientific rigor across global CMC regulatory filings
Provide strategic oversight for post-approval changes, including site changes, process improvements, and supply chain optimization
Interpret and apply evolving CMC regulatory requirements and guidance globally
Partner closely with Drug Substance, Drug Product, Analytical Development and QC, Manufacturing, Supply Chain, Quality, and Program Management to align regulatory strategy with technical and operational plans
Act as a regulatory subject matter expert for tech transfer, global site registration, comparability protocols and control strategy development
Build, mentor, and lead a high-performing global CMC regulatory team, fostering accountability, development, and innovation
Manage external regulatory consultants and regional partners to ensure consistent global execution and local expertise
Qualification
Required
Advanced degree (PhD, PharmD, or MS) in Chemistry, Pharmaceutical Sciences or related scientific discipline
Minimum of 18 years of experience in the biotech/pharmaceutical industry, with at least 10 years in CMC regulatory affairs and global submission experience
Demonstrated success leading global CMC regulatory strategies for small-molecule products
Proven success scaling CMC regulatory function in a public, late-stage biotech/pharma company
Deep understanding of global regulatory frameworks and guidelines (FDA, ICH, EMA, PMDA, NMPA, etc.)
Strong leadership and collaboration skills with a demonstrated ability to work cross-functionally and influence stakeholders at all levels
Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and risk
Ability to thrive in a fast-paced, matrixed, and science-driven environment
Preferred
Experience with oncology development programs and familiarity with accelerated or expedited pathways
Experience with Japan-specific CMC regulatory requirements (e.g., consultations, GQP/GMP compliance, J-NDA format)
Exposure to lifecycle management activities including global variations, site changes, and supply chain adaptations
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
Genetic Engineering News
2026-02-02
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase