CMC Regulatory Lead, Biologics (Phase 3) - Hybrid Boston

A clinical-stage biotech firm is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead the regulatory strategy for a pivotal Phase 3 biologic therapy. This high-impact role requires 10+ years of Regulatory Affairs experience and proven success with late-stage submissions. Responsibilities include defining the CMC regulatory strategy, preparing IND and BLA submissions, and engaging with global regulatory agencies. Candidates should possess strong collaborative communication skills and a deep understanding of biologics manufacturing. This position offers hybrid work flexibility and significant autonomy in a science-driven environment. #J-18808-Ljbffr