Principal Scientist, Regulatory Liaison

Role: Global Regulatory Affairs Principal Scientist for Vaccines and Infectious Diseases, leading regulatory strategy development and implementation for assigned projects throughout their lifecycle. Responsibilities include acting as the sole global regulatory contact, advising cross-functional teams, representing the company in FDA interactions, leading regulatory support for development and marketed products, and reviewing regulatory submissions and reports. The role also involves coordinating with foreign agencies, participating in regulatory due diligence, and preparing for advisory committee meetings. Requirements: MD or PhD with at least 3-7 years of relevant drug development or regulatory experience; excellent communication, organizational, and analytical skills; ability to work independently. Preferred: substantial regulatory experience in vaccines or infectious diseases, specifically antibacterial, antifungal, or antiviral agents. High-Value: focus on vaccines/infectious diseases, regulatory strategy, FDA interactions, global submission review, and cross-functional leadership. Work setup: hybrid in Rahway, NJ or Philadelphia, PA; travel approximately 10%.