Associate Director, Regulatory Affairs

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

May 21, 2025 - 16:20

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