Associate Principal Scientist, Regulatory Liaison

Role: Senior Regulatory Affairs Associate Principal Scientist supporting vaccine and infectious disease products, focusing on global regulatory strategy and submissions. Responsibilities: manage agency communications, prepare regulatory documents (INDs, marketing applications, pediatric plans), track and shepherd responses, develop background packages, and participate in agency meetings. Collaborate with cross-functional teams including Regulatory Operations, Clinical Safety, CMC, and Clinical Research to align regulatory strategies and support lifecycle maintenance of VID programs. Conduct research on regulations and competitive intelligence to inform strategy and assist in process improvements. Qualifications: Ph.D., MD, or related doctoral degree in biological sciences or chemistry, with 3+ years (Master’s) or 6+ years (Bachelor’s) relevant industry experience. Strong communication, organizational, scientific, and analytical skills required. Preferred: prior regulatory experience, especially in anti-infectives or vaccines. High-Value: vaccine modality, infectious disease focus, global regulatory strategy, agency interactions, GxP compliance, lifecycle management, hybrid work setup; no travel required.