Senior Director, Regulatory Strategy

Role: Senior Director of Regulatory Strategy overseeing global/regional regulatory planning for development programs in emerging diseases, registered medicines, or marketed products. Responsibilities: lead regulatory strategy development from first-in-human to post-marketing; represent GRA on development teams; advise senior management; manage project timelines and resources; influence regulatory environment through industry participation; drive process improvements; lead GRA teams including coaching and mentorship. Requirements: Bachelor's in Biology, Chemistry, or related field; 12+ years in pharmaceutical/biotech regulatory affairs with 5+ years in management; deep expertise in global regulatory frameworks, clinical development, and submission strategies; strong leadership and communication skills; ability to operate in matrix environments. HighValue: experience with biologics or small molecules in clinical development (FIH to post-market); global/regional regulatory leadership; strategic planning in emerging disease areas; stakeholder collaboration across cross-functional teams; hybrid role based in Boston or Washington, D.C., with flexible onsite/hybrid work.