Associate Director, CMC Regulatory

Revolution Medicines is seeking a strategic and hands-on Associate Director, CMC Regulatory to execute CMC regulatory strategies and support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products.

Requirements

• Develop, lead, and implement global CMC regulatory strategies to support clinical development, registration, and post-marketing activities.
• Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions.
• Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the development of the investigational product(s) and marketed products.
• Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications.
• Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities