Associate Principal Scientist, Global Regulatory Lead

Role: Associate Principal Scientist, Global Regulatory Lead, focusing on regulatory strategies for medical devices and combination products (MDCPs). Objectives: develop and execute global regulatory plans to optimize label claims and expedite approvals across US, EU, and other markets. Responsibilities: manage projects independently as the main global regulatory contact; lead the preparation, review, and submission of CMC documentation for post-approval and registration activities; coordinate cross-functional global regulatory teams; interact directly with agencies (FDA, EMA, Notified Bodies) at all development phases; review applications, reports, and protocols; provide strategic regulatory advice throughout product lifecycle; and ensure compliance with worldwide regulations. Qualifications: Ph.D., Pharm.D., or M.D. with 3+ years drug development experience or B.S./M.S. with 5+ years in device or drug regulatory affairs; fluency in English; strong knowledge of US/FDA and EU regulations; proven leadership in managing complex regulatory programs; excellent communication, negotiation, and strategic thinking skills. High-Value: expertise in medical devices and combination products, regulatory submissions, post-market activities, and global agency interactions. Work setup: onsite with no specified travel requirements.