Associate Principal Scientist, Regulatory Liaison

Role: Support global regulatory strategies for Vaccine and Infectious Disease (VID) products, encompassing regulatory submissions, agency communication, and lifecycle management. Responsibilities: assist in preparing submissions (e.g., INDs, marketing applications), develop regulatory background packages, participate in agency meetings, and collaborate across functions such as Clinical, CMC, and Safety. Conduct regulatory research and help refine strategy documents, ensuring compliance and effective communication with global agencies. Qualifications: Ph.D., MD, or a related doctorate in biological sciences or chemistry; 3+ years (with master's) or 6+ years (with bachelor's) in pharmaceutical regulatory affairs; excellent communication, organizational, and analytical skills. Preferred: prior regulatory experience, especially in drug development or vaccines, with knowledge of GxP and lifecycle management. High-Value: biologics or vaccines within early to mid-phase development, involved in regulatory agency interactions, submissions, and compliance. Work setup: hybrid on the US East Coast; no travel required.