Associate Director, CMC Regulatory

Role Summary

Associate Director, CMC Regulatory at Revolution Medicines. Lead development and implementation of global CMC regulatory strategies to support clinical development through registration and post-marketing activities, coordinating CMC sections of regulatory submissions for the pipeline products.

Responsibilities

• Develop, lead, and implement global CMC regulatory strategies to support clinical development through registration and post-marketing activities.
• 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.
• Collaborate 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.
• Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
• Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed‚Äôs products.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Qualifications

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• 10+ years of pharmaceutical / biotech drug development experience with 5+ years of global CMC regulatory affairs.
• Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
• 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 excellent interpersonal skills.

Skills

• Global CMC regulatory affairs management
• Regulatory submissions (IND, IMPD/CTA, NDA, MAA)
• Cross-functional collaboration
• Strategic regulatory thinking
• Change control and lifecycle management

Education

• BA/BS required; advanced degree (MSc/PhD) preferred

Additional Requirements

• Onsite role at headquarters in Redwood City, CA; travel not specified as a requirement.