Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

Role: Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leading global regulatory strategy for complex CGT products, including BLA submission and health authority interactions. Responsibilities: develop and execute regulatory plans, lead global teams, manage key stakeholder relationships, and oversee regulatory deliverables across indications such as multiple myeloma. Provide strategic guidance on expedited pathways, participate in governance, and ensure product compliance and lifecycle management. Requirements: advanced science degree, 7-10 years in regulatory affairs, proven success in cell/gene therapy, oncology experience (preferably multiple myeloma), strong leadership and stakeholder management skills, and experience with global regulatory agencies (FDA, EMA). Preferred: leadership in product approvals, experience with autoimmune conditions, and mentoring capabilities. HighValue: focus on cell/gene therapies, oncology, late-stage development, BLA submissions, high-profile/complex programs, cross-functional leadership, external stakeholder engagement, and global regulatory strategy. WorkSetup: flexible, with onsite/remote balance, no travel specifics provided.