Vice President, Regulatory Affairs

Role: Vice President of Regulatory Affairs leading global regulatory strategies for Aura Biosciences' oncology portfolio, with a focus on ocular cancer indications. Responsibilities: develop and execute regulatory plans, manage interactions with agencies (FDA, EMA, etc.), oversee regulatory submissions (INDs, NDAs, BLAs, MAAs), collaborate with clinical development on study design and registration strategies, and support product lifecycle management and commercialization efforts. Requirements: advanced scientific degree (PhD, PharmD, MD preferred), 15+ years' experience in regulatory affairs within biotech/pharma, proven success in global product approvals, deep knowledge of U.S. and international regulations, extensive agency interaction experience. Preferred: expertise in ocular oncology, solid tumors, rare cancers, immuno-oncology, or targeted therapies; prior experience with product launches and working in publicly traded biotech firms. HighValue: focus on late-stage oncology development, biologics/targeted therapies, global regulatory strategy, interaction with major health authorities, and leadership in clinical and commercial regulatory activities. WorkSetup: not specified.