Director, CMC Regulatory Strategy & Global Submissions

Corvus Pharmaceuticals, Inc.; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Corvus Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through NDA/MAA and lifecycle management.

Reporting to the VP of Regulatory Affairs, the role collaborates with CMC, Quality, Clinical and Operations to ensure timely, compliant submissions and lifecycle activities, with risk mitigation and clear regulatory guidance.

Qualifications

• Minimum 10+ years of regulatory affairs experience in biotech/pharma.
• Experience supporting small molecules and global submissions (IND/CTA, NDA/MAA).
• Deep knowledge of CMC development, modules 2/3, change control, and life-cycle strategy.
• Familiarity with FDA, EMA, ICH guidelines and international regulatory expectations.

Responsibilities

• Develop and execute global CMC regulatory strategies across all development phases.
• Provide regulatory guidance on manufacturing changes, comparability, and controls.
• Lead preparation/authoring of CMC sections for INDs/CTAs/Amendments and health authority interactions.
• Oversee NDA/MAA submissions, lifecycle management, and change control assessments.
• Ensure alignment of CMC documentation with overall regulatory strategy and timelines.
• Support inspection readiness activities with Quality and Manufacturing teams.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory writing

Communication

IND/CTA submissions

NDA/MAA submissions

Education

Bachelor’s degree in life sciences

MS/PhD/ PharmD preferred

Job description

Corvus Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through NDA/MAA and lifecycle management.

Reporting to the VP of Regulatory Affairs, the role collaborates with CMC, Quality, Clinical and Operations to ensure timely, compliant submissions and lifecycle activities, with risk mitigation and clear regulatory guidance.