Director of Regulatory Affairs

Role: Director of Regulatory Affairs/Global Regulatory Lead for a clinical-stage biopharma developing next-generation CAR T-cell therapies targeting solid tumors and hematologic malignancies. Objectives include defining and executing global regulatory strategies from early clinical phases through licensure, ensuring alignment with regional agencies, and expediting product development and approval. Responsibilities encompass representing regulatory teams in cross-functional meetings, managing interactions with authorities like the FDA and EMA, leading negotiations, and supporting submissions such as INDs, BLAs, and MAAs. The role involves close collaboration with CMC, Clinical Development, and Medical Affairs teams, reviewing regulatory documents, and mentoring staff. Requirements: Bachelor’s in Life Sciences (advanced degrees preferred), at least 15+ years in biopharma with 8+ years in Regulatory Affairs, with substantial experience in cell and gene therapy, especially CAR-T modalities. Proven track record leading regulatory submissions, interacting with agencies, and understanding FDA regulations for ATMPs. Preferred skills include strategic thinking, negotiation, and working in fast-paced, matrix environments. High-value specifics: focus on cell/gene therapy, immuno-oncology indications, clinical-stage programs, regulatory submissions, agency negotiations, and cross-functional leadership. Work setup: based in Seattle or South San Francisco, with no travel details specified.