Principal Scientist, Regulatory Liaison

Role: Global Regulatory Affairs Principal Scientist specializing in Vaccines and Infectious Diseases, leading regulatory strategies for developmental and marketed products in this therapeutic area. Responsibilities include developing worldwide regulatory plans to optimize labeling and approval timelines, providing expert regulatory guidance throughout product lifecycle, leading cross-functional global regulatory teams, and managing external agency interactions such as FDA communications, advisory committees, and international agencies. The position involves reviewing and approving key regulatory documents, supporting clinical trial approval processes, and participating in licensing due diligence. Qualifications: M.D. or Ph.D. in biological sciences, chemistry, or related field; minimum 3 years (MD) or 5 years (Ph.D.) of relevant drug development/regulatory experience; strong communication, organizational, and scientific analysis skills. Preferred: Experience in vaccines or infectious diseases, especially antibacterial, antifungal, or antiviral agents. High-value biopharma specifics include focus on vaccine/infectious disease development, regulatory submissions, and interaction with global health agencies. Location: Rahway, NJ or Philadelphia; hybrid work model with ~10% travel; senior-level individual contributor role.