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Join Enveda as a Sr. VP, Head of Regulatory in a remote capacity and help us transform natural compounds into life-changing medicines. Your expertise in global regulatory strategy will be critical in accelerating our mission to advance first-in-class small molecule and combination product programs because every breakthrough starts with bold questions and brave actions.
Job Responsibility:
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages
Build and manage a high-performing regulatory team across strategy, operations, and publishing
Requirements:
Advanced degree (PhD, PharmD, MSc, or JD) in life sciences or regulatory sciences
15+ years of global regulatory affairs experience in biotech/pharma, including successful submissions
Experience leading regulatory strategy for first-in-class or novel MOA products
Strong written and verbal communication skills with the ability to represent the company with regulators and external partners