Job Summary

A company is looking for a CMC Regulatory Affairs Project Manager.

Key Responsibilities:

• Develop CMC regulatory strategies and contingency plans for biologic and small molecule drug products
• Determine regulatory requirements for CMC and GMP submissions
• Prepare and review CMC and GMP documents for regulatory authorities

Required Qualifications:

• 5-7 years of CMC regulatory experience in the pharmaceutical industry
• Comprehensive knowledge of drug development process, GMP, and regulatory requirements for biologics and small molecules
• Experience preparing CMC sections for FDA and equivalent submissions
• Bachelors in Pharmaceutical Sciences or Chemistry, or related field
• RAC certification is a plus