Director, CMC Regulatory
$230k - $270kCorvus Pharmaceutical
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
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