Director CMC Regulatory

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

Department/Group: Regulatory Affairs
Location: South San Francisco, CA
Position Type: Full time

Position Overview:

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

Key Responsibilities:

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management)
• Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and control strategies
• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, EMA, Health Canada, PMDA)
• Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments
• Lead preparation of CMC Briefing documents and health authority interactions
• NDA/MAA and supplements/variations preparation and submissions
• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
• Oversee document quality, consistency, and compliance with global regulatory requirements
• Represent regulatory in change control assessments
• Support inspection readiness activities in collaboration with Quality and Manufacturing teams

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred
• Minimum of 10+ years of regulatory affairs experience in biotech/pharma

Preferred Skills:

• Experience supporting small molecules required (familiarity with additional modalities desirable).
• Experience with IND/CTA, NDA/MAA compilation and submissions.
• Deep knowledge of CMC development for small molecules, Module 3 structure and expectations, and comparability and change management strategies.
• Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)
• Proven ability to operate effectively in a small, fast-paced biotech environment
• Strong cross-functional leadership and influencing skills without direct authority
• Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies