Revolution Medicines · 5 months ago
Senior Manager, CMC Regulatory
Redwood City, California, United States
Full-time
Onsite
Senior Level
$158K/yr - $198K/yr
7+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Senior Manager, CMC Regulatory will be responsible for developing and implementing global CMC regulatory strategies, ensuring compliance with regulatory requirements, and coordinating CMC regulatory activities for clinical development and marketing approval of pipeline products.
Health CareLife ScienceMedical
Responsibilities
Collaborate, and manage the CMC regulatory activities for global clinical trials, ensuring compliance with regulatory requirements across regions (FDA, EMA, APAC, etc.)
Collaborate with internal stakeholders to support the preparation of CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs
Assess changes to clinical trial materials or processes and prepare the necessary documents for regulatory amendments
Identify and mitigate regulatory risks, manage CMC timelines and milestones, and ensure the timely submission of high-quality CMC dossiers to support clinical trials
Provide updates to senior management on regulatory activities and submission progress
Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders
Represent department in cross-functional project teams
Participate in the regulatory process initiatives and improvement activities
Qualification
Required
BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field
7+ years of pharmaceutical / biotech drug development experience in CMC development of NCEs / small molecules with 3+ years of CMC regulatory experience
Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues
Demonstrated experience in effective collaboration with internal and external stakeholders
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment
Effective written and verbal communication skills and good interpersonal skills
Preferred
Advanced degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field
Hands on experience managing CMC submissions supporting global trials (US, EU, APAC, LATAM)
A collaborative team player who adapts quickly to new challenges with proven ability to thrive in a fast-paced environment, with a hands-on and result-driven approach and a strategic mindset
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