About this role
Director, Regulatory CMC at Calico. Location: South San Francisco, California, United States. Role: design strategies, coordinate submissions, lead meetings Requirements: 10+ years in biopharma with at least 7 years in CMC Regulatory Affairs; PhD or PharmD preferred; experience with NDA/BLA; GMP/ICH knowledge; strong regulatory interactions. Category: Research and Development (R&D) Seniority: Senior Level Tools: GMP, ICH guidelines, FDA, EMA, CTD Commitment: Full Time Workplace: Onsite Languages: English