Revolution Medicines · 19 hours ago
Associate Director, CMC Regulatory
United States
Full-time
Remote
Lead/Staff, Director/Executive
$180K/yr - $225K/yr
10+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Associate Director, CMC Regulatory will be responsible for developing and implementing CMC regulatory strategies to support clinical development and marketing approval of the company's pipeline compounds/products.
Health CareLife ScienceMedical
Responsibilities
Develop, lead, and implement global CMC regulatory strategies to support the clinical development through registration and post-marketing activities
Lead the preparation and maintenance of the 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
Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met
Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives
Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle
Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed’s products
Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders
Qualification
Required
BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field
10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs
Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM)
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 excellent interpersonal skills
Preferred
Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable
Working experience and content knowledge in CMC development of NCEs / small molecules or equivalent
Self-driven, proactive, and able to operate independently while fostering collaboration across departments
Ability and desire to coach and mentor junior regulatory CMC RA staff
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