Associate Director, Regulatory CMC

We are seeking an Associate Director, Regulatory CMC to execute global regulatory CMC strategies and provide expert guidance to manufacturing and quality teams.

Requirements

• Bachelor's degree and a minimum of 8 years of experience in Regulatory CMC for biotherapeutics
• Biologics experience required, drug/device combination product experience a plus
• Demonstrated track record of successful interactions with FDA and other Health Authorities related to CMC submissions
• Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development
• Preparation of Quality sections of regulatory dossiers, including IND/CTA/IMPDs, briefing documents, and BLA/MAAs
• Strong interpersonal skills and the ability to collaborate effectively with technical area experts
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork
• Excellent communication, writing, and presentation skills