Sr. Director, Regulatory Strategy, Infectious Disease

Role: Senior Director of Regulatory Strategy at Moderna, leading global regulatory planning for mRNA infectious disease vaccines. Responsibilities: develop and execute regulatory strategies, oversee submissions, advise on clinical and nonclinical development, monitor regulatory trends, manage relationships with health agencies, and lead a team of regulatory strategists. Qualifications: BA/BS in science/engineering; 12+ years in pharma, including 8+ in regulatory strategy with vaccine development; deep knowledge of FDA, EU, ICH guidelines; track record of securing approvals; experience with regulatory filings (CTD), and leading agency meetings. High-Value: mRNA platform, infectious disease vaccines, regulatory submissions, global Health Agency interactions, vaccine development phases, direct experience with major NDA/BLA/MAA applications. WorkSetup: hybrid work model with a focus on in-office collaboration, based in Cambridge or East Coast hubs; no specific travel demands stated.