Senior Manager, Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Regulatory Affairs CMC.

Key Responsibilities:

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines
• Personally author sections of Module 2 and 3, including QOS, drug substance, and drug product
• Lead and deliver global submissions, ensuring timeliness, quality, and completeness

Required Qualifications:

• Bachelor's degree with a minimum of 5+ years of experience in CMC regulatory affairs
• Experience as the primary CMC regulatory lead for clinical stage programs
• Hands-on authoring experience for IND and IMPD submissions
• Strong understanding of global CMC regulatory requirements and guidelines
• Proficiency with regulatory submission and document management systems