Director, Regulatory Affairs Strategy - Genetics Medicine

Role: Lead global regulatory strategy for Regeneron's Genetic Medicine portfolio, overseeing submissions and interactions with health authorities. Responsibilities: develop and maintain regulatory plans at study, indication, and program levels; lead IND/CTA and BLA submissions; interpret regulatory feedback; manage health authority interactions; ensure timely, compliant regulatory documentation; mentor regulatory staff; serve as cross-functional regulatory expert. Requirements: MD, Ph.D., Pharm.D., or equivalent; 10+ years in pharma/biotech industry, with 7+ years in regulatory affairs, including liaising with agencies; strong knowledge of US FDA and international regulations; experience managing or collaborating with CROs on global clinical trial applications; excellent communication skills. HighValue: experience in regulatory strategy for biologics or gene therapies, IND/CTA/BLA submissions, global health authority interactions, and managing complex projects in a fast-paced environment. WorkSetup: onsite 4 days/week in Tarrytown, NY or Warren, NJ, with relocation support.