Director, CMC Regulatory (On-site role) Corvus Pharmaceutical San Francisco, CA Job Details Full-time $230,000 - $270,000 a year 11 hours ago Qualifications Bachelor's degree Pharmaceutical company experience Manufacturing company experience Full 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, Manufacturi ng, 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 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 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 p5RFBEBp7g