Sr. Director, Global Regulatory Strategy, Oncology

Role: Senior Director of Regulatory Strategy at Moderna, focusing on global regulatory planning and oversight for oncology programs utilizing mRNA technology. Responsibilities: develop and implement regulatory strategies, lead submissions and amendments, maintain relationships with health agencies, advise project teams, and ensure compliance with international regulations. Manage regulatory documents, policies, and agency negotiations; oversee global development plans and resource allocation; and lead process improvements. Qualifications: BA/BS in a scientific or engineering field; 12+ years in pharma, with 8+ years in regulatory strategy, especially in oncology; deep knowledge of US/EU regulations, CTD filings, and regulatory pathways; proven success in securing product approvals; experience leading regulatory meetings and managing teams. Preferred: advanced degree or professional certification, successful delivery of major applications (NDA/BLA/MAA). High-Value: oncology therapeutics, messenger RNA platform, global regulatory leadership, complex portfolio management, and experience with regulatory agencies. Work setup: based at Cambridge headquarters with hybrid work model; no specific travel requirements stated.