Remote Associate Director, CMC Regulatory Strategy

revolutionmedicines; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

Revolution Medicines seeks an Associate Director, CMC Regulatory to lead global regulatory strategies for clinical development and lifecycle management of RAS(ON) candidates. You will coordinate CMC sections for INDs, IMPDs, NDAs and MAAs, ensuring timely submissions and regulatory alignment across US, EU, APAC and LATAM.

Collaborating with CMC SMEs, CROs and project teams, you’ll drive regulatory excellence, risk assessment and lifecycle changes while guiding cross-functional teams in a

Qualifications

• BA/BS in Pharmaceutical Science, Chemistry, Chemical Engineering or closely related field.
• 10+ years in pharmaceutical/biotech drug development with 5+ years in global CMC regulatory affairs.
• Experience with global CMC submissions (IND, IMPD/CTA, NDA, MAA) across US, EU, APAC, LATAM.
• Solid knowledge of GMP quality regulations and regulatory considerations for development and marketed products.

Responsibilities

• Develop, lead, and implement global CMC regulatory strategies for clinical development and post-marketing activities.
• Lead preparation and maintenance of CMC sections for regulatory submissions (IND, IMPD/CTA, NDA, MAA).
• Serve as CMC regulatory representative on project teams and ensure regulatory requirements are met.
• Collaborate with regulatory teams, SMEs and CROs to meet submission timelines and regional requirements.
• Provide regulatory assessments on CMC changes, deviations, investigations throughout product life cycle.

Skills

Regulatory strategy

Global collaboration

Regulatory submissions

Cross-functional coordination

Education

BA/BS in Pharmaceutical Science

Chemistry or Chemical Engineering

Advanced degree desirable

Tools

IND submissions

IMPD/CTA submissions

NDA/MAA submissions

Job description

Revolution Medicines seeks an Associate Director, CMC Regulatory to lead global regulatory strategies for clinical development and lifecycle management of RAS(ON) candidates. You will coordinate CMC sections for INDs, IMPDs, NDAs and MAAs, ensuring timely submissions and regulatory alignment across US, EU, APAC and LATAM.

Collaborating with CMC SMEs, CROs and project teams, you’ll drive regulatory excellence, risk assessment and lifecycle changes while guiding cross-functional teams in a