Regulatory CMC Associate Director

Job Summary

A company is looking for an Associate Director, Regulatory CMC.

Key Responsibilities

• Provide leadership and strategic direction for regulatory CMC deliverables, including drug/device combination products
• Lead planning and support development for timely global CMC regulatory submission documents
• Act as primary contact with Health Authorities for CMC-related matters and conduct agency meetings

Required Qualifications

• Bachelor's degree with a minimum of 8 years of experience in Regulatory CMC for biotherapeutics
• Demonstrated track record of successful interactions with FDA and other Health Authorities
• Expert understanding of scientific principles and regulatory CMC requirements for global drug development
• Experience in preparing Quality sections of regulatory dossiers, including IND/CTA/IMPDs and BLA/MAAs
• Strong project management skills and ability to work in a fast-paced environment