Senior Manager CMC Regulatory Affairs

Job Summary

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

Key Responsibilities

• Provide CMC regulatory strategy input and expertise for biologic and small molecule drug products
• Prepare, coordinate, and review CMC and GMP related documents for regulatory submissions
• Independently manage preparation of INDs, BLAs, CTAs, and amendments within company timelines

Required Qualifications, Training, and Education

• Bachelor's in Pharmaceutical Sciences, Chemistry, or related field; advanced degrees preferred
• 7 years of CMC regulatory experience in the pharmaceutical industry
• Comprehensive knowledge of drug development processes and CMC regulatory requirements
• Experience in preparing CMC sections for FDA and equivalent submissions for Europe and Canada
• RAC certification is a plus