Global Regulatory Lead, Biologics & BLA Strategy

A leading healthcare consulting firm is seeking a Senior Global Regulatory Affairs Program Lead to manage the end-to-end regulatory strategy for a monoclonal antibody BLA. This pivotal role involves complex coordination across multiple vendors and Health Authorities, alongside deep biologics expertise. The ideal candidate will have extensive experience in global regulatory affairs and a strong scientific background. This is a long-term engagement focused on supporting both approval and post-approval processes, promoting career development while ensuring successful submissions.
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