Director, CMC Regulatory Strategy - Small Molecules

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, 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.