CMC Regulatory Affairs Specialist Small Molecules

Summary: Responsible for preparing and managing CMC regulatory submissions for small-molecule drug products, ensuring compliance with global regulatory requirements. The role involves authoring Module 3 documents in eCTD format and coordinating with cross-functional teams. The specialist will also manage post-approval changes and respond to regulatory authority queries. This position requires extensive experience in CMC Regulatory Affairs and knowledge of small-molecule drug development.

Key Responsibilities:

• Prepare and review CMC sections for IND, NDA, ANDA, and MAA submissions
• Author Module 3 (Quality) documents in eCTD format
• Ensure compliance with FDA, EMA, Health Canada, and ICH guidelines
• Support manufacturing, analytical, and stability data review
• Manage post-approval changes and lifecycle submissions
• Coordinate with cross-functional teams (QA, Manufacturing, R&D)
• Respond to regulatory authority queries and deficiency letters

Key Skills:

• 10+ years CMC Regulatory Affairs experience
• Strong knowledge of small-molecule drug development
• Experience with eCTD and Module 3
• Knowledge of GMP and global regulatory guidelines

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other