Regulatory CMC Manager

Job Summary

Supporting the Chief Regulatory Officer, the full-time salaried Regulatory CMC Manager will manage regulatory CMC activities across the product portfolio by authoring and coordinating CMC sections for submissions, overseeing CMC deliverables, and collaborating with cross-functional teams to ensure accuracy and completeness of documentation.

Key responsibilities

• Author and coordinate CMC sections for regulatory submissions, ensuring consistency and regulatory readiness
• Manage timelines and deliverables for CMC activities, proactively identifying risks and bottlenecks
• Collaborate with various departments to support CMC deliverables and responses to health authority inquiries

Required qualifications

• Bachelor's degree in a related scientific field (advanced degree preferred)
• 5-7 years of CMC experience supporting biologic and/or pharmaceutical development programs
• Strong background in cGMP manufacturing and analytical development
• Demonstrated experience authoring CMC sections for regulatory submissions such as INDs and BLAs
• Experience working with CDMOs, manufacturing facilities, or contract laboratories is strongly preferred