Senior Director Regulatory Affairs - ACH

Role: Senior Director of Regulatory Affairs leading global strategies for late-stage Skeletal Dysplasia programs, focusing on registration, approval, and lifecycle management. Responsibilities: develop and execute comprehensive regulatory plans, lead interactions with health authorities (FDA, EMA, etc.), provide regulatory guidance within cross-functional teams, oversee global submissions, and support accelerated pathways. Must anticipate regulatory risks, communicate feedback, and ensure alignment for indications and labeling. Requirements: Bachelor’s in a scientific field (advanced degree preferred), 10+ years in global regulatory strategy, with proven experience in late-stage development and registration of Skeletal Dysplasia therapies, including NDA/BLA/MAA submissions and health authority interactions. High-Value: extensive knowledge of regulatory pathways for skeletal dysplasia, experience with accelerated/regulatory pathways, cross-regional strategy expertise, and leadership in a high-growth biotech setting. Work setup: remote flexibility with periodic in-person collaboration; up to 20% travel.