Senior Director, CMC Regulatory

Kardigan is seeking a Senior Director, CMC Regulatory to support its mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Senior Director will lead CMC Regulatory activities to advance Kardigan's late-stage clinical assets through clinical development and towards marketing approval.

Requirements

• Lead the development and execution of CMC regulatory strategies
• Manage regulatory interactions with global health authorities
• Provide regulatory expertise on CMC strategies to cross-functional teams
• Ensure compliance with relevant global CMC requirements
• Evaluates proposed manufacturing and quality changes for impact to ongoing and existing submissions

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Four Day Work Week