Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, CMC Regulatory Affairs based in the United States.
This is a senior leadership opportunity at the intersection of regulatory strategy, biologics innovation, and advanced cell and tissue therapies. The role carries enterprise-wide responsibility for shaping and executing CMC regulatory strategy across complex development, clinical, and manufacturing programs. You will lead regulatory submissions, guide global compliance strategy, and serve as a key liaison with health authorities, including the FDA and international agencies. The position requires close partnership with Manufacturing, Quality, MSAT, and Process Development teams to ensure alignment across the product lifecycle. You will also play a critical role in identifying and mitigating regulatory risks while enabling scalable, compliant manufacturing operations. This is a highly visible role where your expertise directly impacts the advancement of transformative therapies for patients worldwide.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, CMC Regulatory Affairs based in the United States.
This is a senior leadership opportunity at the intersection of regulatory strategy, biologics innovation, and advanced cell and tissue therapies. The role carries enterprise-wide responsibility for shaping and executing CMC regulatory strategy across complex development, clinical, and manufacturing programs. You will lead regulatory submissions, guide global compliance strategy, and serve as a key liaison with health authorities, including the FDA and international agencies. The position requires close partnership with Manufacturing, Quality, MSAT, and Process Development teams to ensure alignment across the product lifecycle. You will also play a critical role in identifying and mitigating regulatory risks while enabling scalable, compliant manufacturing operations. This is a highly visible role where your expertise directly impacts the advancement of transformative therapies for patients worldwide.