Director, CMC Regulatory

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of RevMed's pipeline compounds / products.

Responsibilities:

• Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of the investigational products.
• 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.
• Work 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.
• Participate in the interactions with FDA and other global regulatory authorities as appropriate.
• Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
• Participate in the regulatory process initiatives and improvement activities.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Required Experience, Skills and Education:

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• 15+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
• 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 Skills:

• Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• Extensive global experiences including US, EU, UK, Canada, APAC, LATAM throughout the product lifecycle.

The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

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