Associate Director, CMC Regulatory

Responsibilities

• Develop, lead, and implement global CMC regulatory strategies to support clinical development through registration and post-marketing activities
• Provide CMC regulatory leadership for global clinical trial execution, including RevMed-sponsored trials and external collaborations
• 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
• Collaborate with corporate regulatory teams, CMC SMEs, and CROs to identify regional CMC requirements
• Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations
• Lead internal process improvements and SOP development

Requirements

• BA/BS degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
• Minimum of 10 years of experience in pharmaceutical/biotech drug development
• At least 5 years of experience in global CMC regulatory affairs
• Experience leading global clinical and commercial submissions (IND, IMPD/CTA, NDA, MAA) across US, EU, APAC, and LATAM
• Solid knowledge of US and international GMP quality regulations
• Experience with small molecules (NCEs) and managing complex CMC technical documentation
• Ability to manage multiple projects in a fast-paced, matrixed environment

Preferred Qualifications

• Advanced degree (PhD, PharmD, MSc) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field

About the Company

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.