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.

• Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of the investigational products.

• Led 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 PDM 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 the 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 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 the product life cycle.

• Participate in the regulatory process initiatives and improvement activities.

• Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.

Required Experience, Skills, and Education:

• Preferably advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is desirable.

• 15+ years of pharmaceutical/biotech drug development experience with 5 + years of experience in 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.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $195,000 to $245,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.