Regulatory CMC Manager

Job Summary

Supporting international regulatory efforts, the full-time Regulatory CMC Manager will execute lifecycle management strategies and oversee the preparation and submission of regulatory CMC documentation while working remotely on Eastern Time.

Key responsibilities

• Execute Lifecycle Management (LCM) strategy and submissions for marketed products in international regions
• Plan and execute international regulatory CMC submissions, ensuring cross-functional alignment and content creation
• Review CMC sections of regulatory submissions and interact with regulatory agencies for compliance guidance

Required qualifications

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or a related life-science field
• Minimum of 5 years of experience in the pharmaceutical industry or a related field
• Proficiency in regulatory guidelines from FDA, EMA, ICH, and other international agencies
• Experience supporting Small Molecule programs is preferred
• Strong planning and prioritization skills with demonstrated results