Director, CMC Regulatory

Corvus Pharmaceutical; San Francisco (CA); On-site; USD 230,000 - 270,000; Full time

Job summary

Corvus Pharmaceutical, a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs.

This role partners with CMC, Technical Operations, Quality and Clinical teams to deliver timely, compliant submissions and lifecycle management, including IND/CTA through NDA/MAA, and to ensure inspection readiness.

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.
• Experience supporting small molecules; IND/CTA, NDA/MAA submissions.
• Deep knowledge of CMC development for small molecules and regulatory expectations.
• Familiarity with FDA, EMA, ICH guidelines.

Responsibilities

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management).
• Provide regulatory guidance on manufacturing changes, comparability approaches, and control strategies.
• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (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.
• Prepare and submit NDA/MAA and associated supplements/variations.
• 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.

Education

Bachelor’s degree in life sciences or related field

Advanced degree (MS, PhD, PharmD) preferred

IND/CTA submissions experience

NDA/MAA submissions experience

Regulatory strategies for small molecules

ICH guidelines familiarity

Cross-functional leadership

Strong written and verbal communication

Regulatory compliance & lifecycle management

Experience in biotech/pharma

Job description

Corvus Pharmaceutical 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, Soquelitnib, 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.

Role and 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
• Prepare and submit NDA/MAA and associated supplements/variations
• 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 and Education Requirements

• 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

Salary Range: $230,000 to $270,000