Associate Director, Regulatory Affairs

Job Summary

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

Key Responsibilities

• Collaborate with cross-functional teams to plan, write, and review CMC sections of regulatory submissions
• Provide regulatory guidance on Module 2/Module 3 content and assess proposed CMC changes for regulatory impact
• Communicate with regulatory Health Authorities and ensure alignment with current regulations and industry guidance

Required Qualifications

• B.S. in a scientific discipline required; advanced degree preferred
• At least 8 years of experience in CMC Regulatory Affairs, with direct experience in development programs through registration
• Demonstrated leadership in regulatory submissions and effective project management
• Strong knowledge of cGMP and drug development regulations, including ICH, FDA, and EMA guidelines
• Experience with eCTD elements and leading interactions with health authorities