CMC Regulatory Affairs Consultant

Job Summary

Seeking a highly experienced CMC Regulatory Affairs Consultant for a remote contract position, who will provide expert-level regulatory support for small molecule drug development, ensuring compliance with global requirements and leading CMC submissions for INDs, NDAs, and MAAs.

Key Responsibilities

• Provide expert-level CMC regulatory support for small molecule drug development, ensuring compliance with global regulatory requirements
• Lead or support the authoring, review, and submission of CMC sections for regulatory filings
• Develop CMC regulatory strategies for early-phase and late-phase programs, guiding teams through pre-approval processes

Required Qualifications

• Extensive experience (7+ years) in Regulatory Affairs CMC, specifically in small molecules
• Proven expertise in early development, late development, and pre-approval regulatory submissions
• Strong knowledge of global CMC regulations, guidance, and best practices
• Experience authoring and reviewing CMC sections of regulatory submissions
• Prior experience in regulatory interactions with FDA, EMA, and other health authorities