Manager, Regulatory Affairs

Role: Regulatory Affairs Manager supporting global development programs, focusing on regulatory strategy, submissions, and lifecycle management for biopharmaceuticals. Responsibilities: prepare and review INDs, CTAs, amendments, and other filings; coordinate global health authority meetings; ensure regulatory compliance; collaborate with external partners; support study start-up, maintenance, and end-of-trial activities; contribute to process improvements. Requirements: Bachelor’s in a scientific discipline; 6+ years in the pharmaceutical industry with 4+ years in Regulatory Affairs; strong knowledge of U.S. and international drug development regulations; excellent communication, organizational, and collaboration skills; experience in fast-paced environments supporting initial INDs/CTAs and marketing applications preferred. HighValue: regulatory strategy for biologics or kinase inhibitor programs, early to late-stage development, global submissions, lifecycle management. WorkSetup: not specified; likely office-based with potential cross-border collaboration.