Associate Director, CMC Regulatory

Responsibilities

• Develop, lead, and implement global CMC regulatory strategies to support clinical development, registration, and post-marketing activities
• Lead the preparation and maintenance of CMC/quality sections for regulatory submissions including IND, IMPD/CTA, NDA, and MAA
• Serve as the CMC regulatory representative on project teams to ensure applicable regulatory requirements are met
• Collaborate with corporate regulatory teams, CMC SMEs, and CROs to identify regional CMC requirements and drive submission timelines
• Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations
• Lead internal process improvements and SOP development to support product globalization
• Maintain knowledge of the global regulatory environment and CMC guidance

Requirements

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field
• 10+ years of pharmaceutical or biotech drug development experience
• 5+ years of experience in global CMC regulatory affairs
• Experience with global CMC submissions (IND, IMPD/CTA, NDA, MAA) across US, EU, APAC, and LATAM
• Solid knowledge of US and international GMP quality regulations
• Working experience in CMC development of NCEs (small molecules)
• Strong collaboration, prioritization, and communication skills

Preferred Qualifications

• Advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, or Chemical Engineering
• Experience in accelerated development programs
• Proactive and able to operate independently in a matrixed environment

About the Company

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.