Associate Director, CMC Regulatory

Role Summary

Associate Director, CMC Regulatory. Responsible for reviewing and preparing CMC sections, ensuring regulatory compliance, and developing regulatory strategies for submissions and post-approval variations.

Responsibilities

• Review drug substance and drug product information for completeness and up to current regulatory standards
• Prepare CMC sections for drug substance and drug product information/data
• Review relevant FDA/EMA/ICH guidelines to ensure completeness
• Prepare responses to FDA/EMA questions
• Develop regulatory strategy for original submission and post approval variations
• Perform regulatory assessment on CMC change controls
• Participate in drug substance and drug product development activities to ensure appropriate data for INDs/NDAs/IMPDs/MAAs are generated
• Work with contract manufacturing companies to address any gaps in information/data
• Collaborate with drug substance, drug product and analytical chemistry subject matter experts to prepare CMC sections

Qualifications

• MS or PhD degree in pharmaceutical sciences or medicinal chemistry
• ~8 to 10 years pharmaceutical R&D experience with at least 3 to 5 years of regulatory CMC experience
• Thorough knowledge and understanding of biologics and sterile products
• Good writing skills

Additional Requirements