Global CMC Regulatory Director

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

Job summary

Corvus Pharmaceuticals, a clinical-stage biopharma company, seeks a Director of Regulatory Affairs CMC to develop global CMC strategies for small molecules and lead regulatory submissions. This role partners with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant submissions and lifecycle management.

The ideal candidate has 10+ years in regulatory affairs, a life sciences degree (advanced degrees preferred), and deep knowledge of CMC Module 3, change management,

Qualifications

• Bachelor's degree in life sciences or related field required.
• Minimum 10+ years of regulatory affairs experience in biotech/pharma.

Responsibilities

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management).
• Lead preparation and authorship of CMC sections for INDs/CTAs/Amendments (Module 2.3, 3).
• Lead preparation of CMC Briefing documents and health authority interactions.
• NDA/MAA submissions and lifecycle management activities; ensure alignment with regulatory strategy and program timelines.
• Support inspection readiness in collaboration with Quality and Manufacturing teams.

Skills

Regulatory strategy

CMC development

Cross-functional leadership

IND/CTA submissions

NDA/MAA submissions

Regulatory intelligence

Excellent communication

Education

Bachelor's degree in life sciences

MS/PhD preferred

Job description

Corvus Pharmaceuticals, a clinical-stage biopharma company, seeks a Director of Regulatory Affairs CMC to develop global CMC strategies for small molecules and lead regulatory submissions. This role partners with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant submissions and lifecycle management.

The ideal candidate has 10+ years in regulatory affairs, a life sciences degree (advanced degrees preferred), and deep knowledge of CMC Module 3, change management,