Job Description
Job Title: Associate Director, CMC Regulatory
This role leads Chemistry, Manufacturing, and Controls (CMC) regulatory activities with a strong nonclinical focus, supporting faculty and staff on product development and regulatory strategy. The Associate Director, CMC Regulatory provides expert guidance on regulatory requirements for animal studies and clinical applications, prepares and supports submissions to health authorities, and partners closely with clinical research teams to advance innovative therapies, including gene therapies and biologics. The position offers the opportunity to work as part of an internal clinical research organization, gain broad exposure across multiple therapeutic areas, and contribute to cutting-edge research within a highly collaborative academic medical environment.
Responsibilities
+ Consult with faculty and staff on product development and regulatory topics with a primary focus on nonclinical and CMC aspects.
+ Provide regulato...
This role leads Chemistry, Manufacturing, and Controls (CMC) regulatory activities with a strong nonclinical focus, supporting faculty and staff on product development and regulatory strategy. The Associate Director, CMC Regulatory provides expert guidance on regulatory requirements for animal studies and clinical applications, prepares and supports submissions to health authorities, and partners closely with clinical research teams to advance innovative therapies, including gene therapies and biologics. The position offers the opportunity to work as part of an internal clinical research organization, gain broad exposure across multiple therapeutic areas, and contribute to cutting-edge research within a highly collaborative academic medical environment.
Responsibilities
+ Consult with faculty and staff on product development and regulatory topics with a primary focus on nonclinical and CMC aspects.
+ Provide regulato...