Director/Senior Director, Regulatory Counsel

Role: Regulatory Counsel supporting Flagship Pioneering’s diverse portfolio of emerging health technologies. Objectives: lead regulatory strategies related to government contracting, GxP compliance, and international expansion; advise on digital health, medical devices, and other innovative platforms. Responsibilities: oversee regulatory efforts tied to government obligations; provide practical guidance on GxP and cross-platform regulatory matters; support clinical development in international markets; monitor regulatory developments and advise leadership; collaborate with compliance to build scalable regulatory capabilities. Requirements: JD from an accredited law school; admission to bar in at least one U.S. state; 6-10 years of legal experience in regulatory law, with expertise in government contracts (FAR/DFARS) and life sciences (GxP, FDA); preferred experience advising on medical devices and international regulatory strategies, especially in China or Australia. Skills: strong subject-matter expertise, ability to translate complex regulations into actionable guidance, sound judgment, negotiation and drafting skills, ability to manage outside counsel, and proficiency with AI legal tools. High-Value: cross-platform regulatory strategy across biotech, digital health, and medical devices; GxP, FDA, international market expansion; in-office role at Cambridge, MA.