Director, Global CMC Regulatory at Revolution Medicines

You're a seasoned pharmaceutical regulatory professional with at least 15 years of experience, including 5 years focused on global CMC regulatory affairs, ideal

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

You're a seasoned pharmaceutical regulatory professional with at least 15 years of experience, including 5 years focused on global CMC regulatory affairs, ideally holding a Bachelor's degree in a relevant scientific field. This leadership role requires deep expertise in CMC development for small molecule new chemical entities and managing complex technical content. **What makes it worth a look...** This full-time, hybrid role at Revolution Medicines, located in Redwood City, California, offers a competitive salary range of USD 211,000 - 264,000 per year. You'll be instrumental in shaping global commercial CMC regulatory strategies for novel targeted therapies. **You might be a good fit if you...** * Have extensive experience leading global CMC regulatory strategy and marketing approval applications across major regions like the US, Europe, and APAC. * Possess strong knowledge of global GMP regulations and current industry practices, with the ability to interpret and apply them. * Have a proven track record of building relationships and interacting with global Health Authorities, including the FDA. * Demonstrate strong project and team leadership capabilities, managing multiple complex programs.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing approvals for RevMed’s product portfolio worldwide.

This position provides leadership for commercial-stage CMC regulatory activities, including original marketing applications, global expansions, and post-approval lifecycle management. This role requires deep expertise in global commercial CMC regulatory frameworks, strong cross-functional leadership, and the ability to proactively anticipate regulatory risks while enabling business objectives.

Responsibilities:

• Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.

• Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations. Manage/lead interactions with Health Authorities as needed.

• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.

• Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.

• Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.

• Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.

• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

• Minimum of 15 years of experience in pharmaceutical / biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.

• Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.

• Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Canada, Europe, UK, APAC, and LATAM regions.

• Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.

• Proven track record of building and maintaining productive relationships with global Health Authorities, including direct interactions with the FDA and other regulatory bodies.

• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

• Effective written and verbal communication skills and interpersonal skills.

• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• Experience supporting global commercial labeling implementation and lifecycle updates, with strong knowledge of global labeling requirements and artwork development/approval processes, including coordination of CMC-related labeling impacts across regions.

• Prior experience in oncology product commercialization is a plus.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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