About this role
Associate Director, Regulatory CMC (Biologics) at Oruka Therapeutics. Location: Waltham, Massachusetts, United States. Role: developing dossiers, leading strategy, managing submissions Requirements: Master's or PhD in life sciences, 6+ years CMC experience with minimum 3+ years regulatory CMC in biologics, cGMP and global regulatory submission expertise (FDA/EMA/ICH), experience authoring Module 3 and combination product submissions. Category: Research and Development (R&D) Seniority: Senior Level Commitment: Full Time Workplace: Hybrid Languages: English