Director of Operations, CMC Regulatory Sciences

Role: Director of Regulatory Sciences leading a team responsible for authoring and coordinating CMC regulatory submissions across biologics, small molecules, cell and gene therapies, and combination products from IND/CTA through NDA/BLA and post-approval. Objectives include developing global CMC regulatory strategies to accelerate product approval and lifecycle management. Responsibilities encompass building and optimizing team workflows, tracking operational metrics, managing capacity and workload distribution, and mentoring staff. The role also involves representing the company externally in industry associations and staying current with international regulatory guidance. Qualifications: BS/BA in life sciences; 10+ years for Associate Director, 12+ for Director, 15+ for Senior Director, with extensive knowledge of FDA, EMA, and other international CMC regulations across modalities. High-Value: expertise in biologics, small molecules, cell/gene therapy, combination products; experience managing cross-functional teams; development stage spanning from IND/CTA to post-market; focus on lifecycle management and regulatory strategy. Work Setup: On-site in Troy, NY, with standard weekday hours.