Associate Director, Regulatory CMC

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 within the pharmaceutical industry Demonstrated leadership in regulatory submissions and effective project management Strong knowledge of cGMP, biologics drug development regulations, and eCTD structure Experience leading interactions with health authorities and managing multiple projects

May 20, 2025 - 18:40

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 within the pharmaceutical industry Demonstrated leadership in regulatory submissions and effective project management Strong knowledge of cGMP, biologics drug development regulations, and eCTD structure Experience leading interactions with health authorities and managing multiple projects